MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
Medimaging Integrated Solution, Inc (Miis)
MEDIMAGING INTEGRATED SOLUTION INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015316279 | 3015316279 | MEDIMAGING INTEGRATED SOLUTION INC. | 1 | N | 2026-01-01 | 3F, No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu Hsinchu (City) TW 30077 |
| 3009197913 | 3009197913 | MEDIMAGING INTEGRATED SOLUTION INC. | 1 | N | 2020-04-25 | 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu Hsinchu - Municipality TW 30076 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 227133 | 1240368615 | K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | HRX | 2025-12-23 |
| 227133 | 1920694356 | K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | EOQ | 2024-05-01 |
| 227133 | 1296377534 | K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | FAJ | 2023-10-06 |
| 227133 | 1804207370 | K223739 | VS Tabletop Tonometer | HKX | 2023-11-08 |
| 227133 | 1049133244 | K214050 | ENT Nasopharyngoscope and Accessories | EOB | 2022-07-01 |
| 227133 | 1405298789 | K193188 | MiiS Horus Eye Anterior Camera | HJO | 2020-01-14 |
| 227133 | 1538684923 | K181260 | MiiS Horus Scope DPT 100 | HKX | 2019-06-21 |
| 132131 | 1538684923 | K181260 | MiiS Horus Scope DPT 100 | HKX | 2019-06-21 |
| 227133 | 1465292767 | K170470 | Digital Eye Anterior Camera | HJO | 2017-10-06 |
| 132131 | 1465292767 | K170470 | Digital Eye Anterior Camera | HJO | 2017-10-06 |
| 132131 | 1537428550 | K120982 | DIGITAL EYE-FUNDUS CAMERA | HKI | 2012-09-28 |
| 227133 | 1537428550 | K120982 | DIGITAL EYE-FUNDUS CAMERA | HKI | 2012-09-28 |
| 132131 | 1221226718 | ||||
| 132131 | 1224333167 | ||||
| 132131 | 1288812525 | ||||
| 132131 | 1600483735 | ||||
| 132131 | 1643726441 | ||||
| 132131 | 1785848475 | ||||
| 132131 | 1810033762 | ||||
| 132131 | 1913227965 | ||||
| 132131 | 1919877933 | ||||
| 132131 | 1979522957 | ||||
| 227133 | 1221226718 | ||||
| 227133 | 1224333167 | ||||
| 227133 | 1288812525 | ||||
| 227133 | 1349856203 | ||||
| 227133 | 1443778242 | ||||
| 227133 | 1530385511 | ||||
| 227133 | 1600483735 | ||||
| 227133 | 1643726441 | ||||
| 227133 | 1723101248 | ||||
| 227133 | 1785848475 | ||||
| 227133 | 1810033762 | ||||
| 227133 | 1913227965 | ||||
| 227133 | 1919877933 | ||||
| 227133 | 1979522957 |
Product Codes Associated With Registrations#
PMN#
VS Tabletop Tonometer
Medimaging Integrated Solution, Inc.
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
Medimaging Integrated Solution, Inc (Miis)
ENT Nasopharyngoscope And Accessories
Medimaging Integrated Solution Inc. (MiiS)
MiiS Horus Eye Anterior Camera
Medimaging Integrated Solution Inc. (MiiS)
MiiS Horus Scope DPT 100
Medimaging Integrated Solution Inc. (MiiS)
Digital Eye Anterior Camera
Medimaging Integrated Solution Inc. (MiiS)
DIGITAL EYE-FUNDUS CAMERA
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS)
GUDID#
MiiS Horus Endoscope Display System - The MiiS Horus Endoscope Display System -Video Box (EVS 700) is plug-and-play visualization modules that are used with endoscope project images onto a monitor.
2026-04-29
MiiS Horus Endoscope Display System - MiiS Horus Endoscope Display System -Tablet (Abbreviated as EDS 500 Tablet) is a high-quality, portable full-HD tablet that is designed to be used with single-use endoscopes. EDS 500 Tablet features advanced image processing with a 14-inch touchscreen ensures continuous optimization of the image quality.
2026-04-29
MiiS Horus scope - MiiS Horus Bronchoscope (ECB 100L) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree. MiiS Horus Bronchoscope (ECB 100L) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
2026-04-29
MiiS Horus scope - MiiS Horus Bronchoscope (ECB 100R) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree. MiiS Horus Bronchoscope (ECB 100R) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
2026-04-29
MiiS Horus scope - MiiS Horus Bronchoscope (ECB 100S) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree. MiiS Horus Bronchoscope (ECB 100S) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
2026-04-29
MiiS Horus Video Box - Image transfer system (Cable-connected Video Box, model name: EVS 100A) is used to transmit the signal captured from Nasopharyngoscope (model name: EES 100).EVS 100A is attached on a tablet. The live imaging or snapshot will present directly on the tablet. The function of ENT Nasopharyngoscope and Accessories are to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment.
2026-04-29
MiiS Horus scope - Nasopharyngoscope (model name: EES 100) is a single-use, flexible, sterile nasopharyngoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected Video Box (EVS 100A).The function of ENT Nasopharyngoscope and Accessories are to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment.
2026-04-29
MiiS - The VS Tabletop Tonometer (model name: IOP 100) is a digital tonometer used to measure intraocular pressure of the eye. The VS Tabletop Tonometer is designed to be used by patients in clinic settings under professional guidance. The intended purpose of the device as an adjunct is to support routine monitoring of eye pressure in the clinic to better understand the eye condition. This device should not be solely or primarily relied upon to prevent, diagnose, or treat ocular conditions.The VS Tabletop Tonometer features an alignment system that positions itself before taking an IOP measurement. Once properly aligned, the device automatically makes an IOP measurement. Measurements are made using an air puff, without any physical object contacting the eye. The VS Tabletop Tonometer is powered by a rechargeable Li-ion battery.
2026-04-29
MiiS Horus scope - MiiS Horus Arthroscope (EJA 100-Direction of view 0°) is a sterile and single-use device designed to be operated with its compatible display system (EDS 500 Tablet or EVS 700 Video Box).The device provides visualization for endoscopic procedures of an interior cavity of the body through a surgical opening. MiiS Horus Arthroscope (EJA 100) have an LED light source and a camera at the distal end of the applied part. The Arthroscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
2026-04-29
MiiS Horus scope - MiiS Horus Arthroscope (EJA 100-Direction of view 30°) is a sterile and single-use device designed to be operated with its compatible display system (EDS 500 Tablet or EVS 700 Video Box).The device provides visualization for endoscopic procedures of an interior cavity of the body through a surgical opening. MiiS Horus Arthroscope (EJA 100) have an LED light source and a camera at the distal end of the applied part. The Arthroscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
2026-04-29
VersaVue Video Box - VersaVue Video BoxThe VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor.
2025-07-23
VersaVue Tablet Power Cord - Israel - 5015
2025-04-15
VersaVue Tablet Power Cord – QA/LB/JO - 5015
2025-04-15
VersaVue Tablet Power Cord – UAE/SA/KW - 5015
2025-04-15
VersaVue Tablet - Global/CE Repair - VersaVue Tablet - Global/CE RepairThe VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor.
2025-04-15
VersaVue Tablet - Global/CE Demo - VersaVue Tablet - Global/CE DemoThe VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor.
2025-04-15
VersaVue Tablet - Global/CE - VersaVue Tablet - Global/CEThe VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor.
2025-04-15
VersaVue™ Power Cord - US/JP/TW - 5015
2023-10-20
VersaVue™ Power Brick Adapter - 5015
2023-10-20
VersaVue™ Tablet Vesa Mount - 5015
2023-10-20
VersaVue™ Tablet - VersaVue Tablet - US/Non-CE RepairThe VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor.
2023-10-20
VersaVue™ Tablet - VersaVue Tablet - US/Non-CE DemoThe VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor.
2023-10-20
VersaVue™ Tablet - VersaVue Tablet - US/Non-CEThe VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor.
2023-10-20
VersaVue™ - VersaVue – Reverse Deflection Demo Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
VersaVue™ - VersaVue - Standard Deflection Demo Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
VersaVue™ - VersaVue - Reverse Deflection Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
VersaVue™ - VersaVue - Standard Deflection Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
VersaVue™ - VersaVue – Reverse Deflection Demo Scope SingleThe VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
VersaVue™ - VersaVue - Standard Deflection Demo Scope SingleThe VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
VersaVue™ - VersaVue - Reverse Deflection Scope SingleThe VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
VersaVue™ - VersaVue - Standard Deflection Scope SingleThe VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults.
2023-10-20
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700-B)
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700TUD-B)
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700TU-B)
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700B)
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 100 Imager (RV100PRO-C)
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 100 Imager (RV100PROC)
2020-03-01