MEDIMAGING INTEGRATED SOLUTION INC.

FDA Registration(s)#

Registration, FEI, Name table
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 table
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
132131	1538684923	K181260	MiiS Horus Scope DPT 100	HKX	2019-06-21
227133	1538684923	K181260	MiiS Horus Scope DPT 100	HKX	2019-06-21
132131	1465292767	K170470	Digital Eye Anterior Camera	HJO	2017-10-06
227133	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	1211338326
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#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HKX	3	2023-11-08
HJO	3	2020-01-14
HKI	2	2012-09-28
HRX	1	2025-12-23
EOQ	1	2024-05-01
FAJ	1	2023-10-06
EOB	1	2022-07-01

GUDID#

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.
MEDIMAGING INTEGRATED SOLUTION INC.
2023-10-20
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
2026-04-29
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
2025-07-23
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
2025-04-15
VersaVue Tablet Power Cord – UAE/SA/KW - 5015
MEDIMAGING INTEGRATED SOLUTION INC.
2025-04-15
VersaVue Tablet Power Cord – QA/LB/JO - 5015
MEDIMAGING INTEGRATED SOLUTION INC.
2025-04-15
VersaVue Tablet Power Cord - Israel - 5015
MEDIMAGING INTEGRATED SOLUTION INC.
2025-04-15
VersaVue™ Power Cord - US/JP/TW - 5015
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
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.
MEDIMAGING INTEGRATED SOLUTION INC.
2023-10-20
VersaVue™ Tablet Vesa Mount - 5015
MEDIMAGING INTEGRATED SOLUTION INC.
2023-10-20
VersaVue™ Power Brick Adapter - 5015
MEDIMAGING INTEGRATED SOLUTION INC.
2023-10-20
Welch Allyn - Eye Fundus Camera: RetinaVue 100 Imager (RV100PROC)
MEDIMAGING INTEGRATED SOLUTION INC.
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 100 Imager (RV100PRO-C)
MEDIMAGING INTEGRATED SOLUTION INC.
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700B)
MEDIMAGING INTEGRATED SOLUTION INC.
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700TU-B)
MEDIMAGING INTEGRATED SOLUTION INC.
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700TUD-B)
MEDIMAGING INTEGRATED SOLUTION INC.
2020-03-01
Welch Allyn - Eye Fundus Camera: RetinaVue 700 Imager (RV700-B)
MEDIMAGING INTEGRATED SOLUTION INC.
2020-03-01