2430TCA with Xmaru W
Rayence Co., Ltd.
RAYENCE CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009048384 | 3009048384 | RAYENCE CO., LTD. | 1 | N | 2026-01-01 | 14,Samsung 1-ro 1-gil & #201, 13, Samsung 1-ro 2-gil Hwaseong-si Gyeonggi KR 18449 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 129452 | 1997874860 | K253800 | 0909FCE, 0909FCE-HS | MQB | 2026-07-31 |
| 129452 | 1752749654 | K243849 | 2430TCA with Xmaru W | MUE | 2025-03-12 |
| 129452 | 1752174859 | K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | MQB | 2024-09-09 |
| 129452 | 1484051235 | K240371 | 0909FCC, 0909FCC-HS | MQB | 2024-03-07 |
| 129452 | 1182260461 | K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | MQB | 2023-06-21 |
| 129452 | 1336229710 | K220689 | Vatech Clismile | NJM | 2022-05-06 |
| 129452 | 1644218080 | K212753 | 0909FCB, 1212FCA | MQB | 2021-10-18 |
| 129452 | 1391783600 | K210985 | 1717FCC | MQB | 2021-04-28 |
| 129452 | 1137707379 | K202902 | 2430MCA with Xmaru W | MUE | 2021-06-21 |
| 129452 | 1402696211 | K202722 | 1212FCA | MQB | 2020-10-26 |
| 129452 | 1968919770 | K201796 | 1717SCV, 1717SGV | MQB | 2020-07-23 |
| 129452 | 1332308946 | K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | LLZ | 2019-04-30 |
| 129452 | 1693002891 | K183478 | ClearON Mobile | LLZ | 2019-03-01 |
| 129452 | 1080511504 | K171420 | 1717SCC_127um and 1717SCC_140um | MQB | 2017-06-09 |
| 129452 | 1744825515 | K171419 | 1717SGC_127um and 1717SGC_140um | MQB | 2017-06-09 |
| 129452 | 1940770336 | K171418 | 1417WCC_127um and1417WCC_140um | MQB | 2017-06-12 |
| 129452 | 1226797611 | K171417 | 1417WGC_127um and 1417WGC_140um | MQB | 2017-06-12 |
| 129452 | 1944499688 | K162519 | 1717WCC / 1717WGC | MQB | 2016-10-06 |
| 129452 | 1972847368 | K162518 | 1012WCC, 1012WGC | MQB | 2016-10-06 |
| 129452 | 1802118863 | K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | LLZ | 2016-04-08 |
| 129452 | 1594901071 | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | MUH | 2015-11-10 |
| 129452 | 1443669391 | K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i | MUH | 2015-07-19 |
| 129452 | 1907050465 | K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector | MQB | 2015-03-27 |
| 129452 | 1023250304 | K141566 | SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC | MQB | 2014-07-16 |
| 129452 | 1890707818 | K141563 | SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC | MQB | 2014-07-16 |
| 129452 | 1143537528 | K140646 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G | MQB | 2014-04-11 |
| 129452 | 1824917781 | K140060 | DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A | MQB | 2014-05-13 |
| 129452 | 1079825484 | K140056 | DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A | MQB | 2014-05-13 |
| 129452 | 1112463788 | K133409 | DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA | MQB | 2014-02-21 |
| 129452 | 1043864608 | K131114 | DIGITAL FLAT PANEL X-RAY DETECTOR | MQB | 2013-09-17 |
| 129452 | 1303253766 | K130935 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA | MQB | 2013-07-02 |
| 129452 | 2072034160 | K123345 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA | MQB | 2013-03-12 |
| 129452 | 1879431284 | K122928 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA | MQB | 2013-01-30 |
| 129452 | 1252187477 | K122919 | DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA | MQB | 2013-01-01 |
| 129452 | 1652463844 | K122182 | DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC | MQB | 2012-08-16 |
| 129452 | 1786519580 | K122173 | DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC | MQB | 2012-10-19 |
| 129452 | 1630847724 | K121132 | EZSENSOR P DIGITAL INTRAORAL SENSOR | MQB | 2012-05-10 |
| 129452 | 1759178301 | K113630 | DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA | MQB | 2011-12-29 |
| 129452 | 1765354551 | K090526 | MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR | MUH | 2009-12-02 |
| 129452 | 1988557310 |
Product Codes Associated With Registrations#
PMN#
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
Rayence Co., Ltd.
0909FCC, 0909FCC-HS
Rayence Co., Ltd.
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
Rayence Co., Ltd.
1212FCA
Rayence Co., Ltd.
1717SCV, 1717SGV
Rayence Co., Ltd.
1012WCC, 1012WGC
RAYENCE CO., LTD.
GUDID#
XmaruView V1 - XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management
2016-09-16
Xmaru PACS - Xmaru PACS is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography.
2016-10-11
ClearON Mobile - ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database. It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.
2019-03-08
Xmaru Pro - Xmaru Pro software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, measurements, automated measurement of bone age from a child's hand X-ray, and function to assist the image reading by detecting abnormal areas on the chest X-ray. Xmaru Pro is complying with DICOM standards to assure optimum communications between network systems. (not approved for mammography) Xmaru Pro offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals.
2020-07-24
Xmaru Podview - Xmaru Podview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Podview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Podview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
2020-07-24
Xmaru Chiroview - Xmaru Chiroview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Chiroview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Chiroview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
2020-07-24
XmaruView V1 - XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. XmaruView V1 performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
2020-07-24
2430TCA - Full-Field Digital Mammography System
2025-04-08
1717WCE - Solid state x-ray imager (flat panel/digital imager)
2024-09-19
1717WCE-HR - Solid state x-ray imager(flat panel/digital imager)
2024-09-19
1717WCE-HS - X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
2024-09-19
1717WCE-GF - X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
2024-09-19
0909FCC - X-ray, Fluoroscopic, image-intensified system
2024-03-21
0909FCC-HS - X-ray, Fluoroscopic, image-intensified system
2024-03-21
1417WCE - X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
2023-06-29
1417WCE-HR - X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
2023-06-29
1417WCE-HS - X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
2023-06-29
1417WCE-GF - X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
2023-06-29
Vatech Clismile - This product is a orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31
Vatech Clismile - This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
2022-05-31