FDA.reportPublic FDA data

0909FCC-HS

Primary DI
08800018602201
Brand
0909FCC-HS
Company
Rayence Co., Ltd.
Model
0909FCC-HS
Device description
X-ray, Fluoroscopic, image-intensified system
Published
2024-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2403710000909FCC, 0909FCC-HSRayence Co., Ltd.2024-03-07MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018602201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018602201088000186022018800018602201

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557804458
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800018600399XmaruView V1XmaruView V12016-09-16
08800018600429Xmaru PACSXmaru PACS2016-10-11
08800018600573ClearON MobileClearON Mobile2019-03-08
08800018600580Xmaru ProXmaru Pro2020-07-24
08800018600597Xmaru PodviewXmaru Podview2020-07-24
08800018600603Xmaru ChiroviewXmaru Chiroview2020-07-24
08800018600610XmaruView V1XmaruView V12020-07-24
088000186022562430TCA2430TCA2025-04-08
088000186022181717WCE1717WCE2024-09-19
088000186022251717WCE-HR1717WCE-HR2024-09-19
088000186022321717WCE-HS1717WCE-HS2024-09-19
088000186022491717WCE-GF1717WCE-GF2024-09-19
088000186021950909FCC0909FCC2024-03-21
088000186021401417WCE1417WCE2023-06-29
088000186021571417WCE-HR1417WCE-HR2023-06-29
088000186021641417WCE-HS1417WCE-HS2023-06-29
088000186021711417WCE-GF1417WCE-GF2023-06-29
08800018600924Vatech Clismile11-12112022-05-31
08800018600931Vatech Clismile 11-12212022-05-31
08800018600948Vatech Clismile 11-12122022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00680211003313PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-10-12
00680211003306PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-22
00680211003290PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-21
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONJAA2026-08-14
00854810007007AirDRIcRco, Inc.MQB2026-07-22
00854810007014AirDRIcRco, Inc.MQB2026-07-22
00854810007120iDRIcRco, Inc.MQB2026-07-22
00854810007199iXRSIcRco, Inc.JAA2026-07-22
00854810007205AirDRIcRco, Inc.MQB2026-07-22
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAA2026-07-08
00680211003276PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-07-06
00848340021879Mitaka DrapeADVANCE MEDICAL DESIGNS, INC.JAA2026-06-25
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14