FDA.reportPublic FDA data

MEDIMAGING INTEGRATED SOLUTION INC.

Matched from indexed company URL: Medimaging Integrated Solution, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30153162793015316279MEDIMAGING INTEGRATED SOLUTION INC.1N2026-01-013F, No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu Hsinchu (City) TW 30077
30091979133009197913MEDIMAGING INTEGRATED SOLUTION INC.1N2020-04-251F, 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 keyListing keyPremarket submissionDeviceProduct codeDecision date
2271331240368615K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)HRX2025-12-23
2271331920694356K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video BoxEOQ2024-05-01
2271331296377534K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxFAJ2023-10-06
2271331804207370K223739VS Tabletop TonometerHKX2023-11-08
2271331049133244K214050ENT Nasopharyngoscope and AccessoriesEOB2022-07-01
2271331405298789K193188MiiS Horus Eye Anterior CameraHJO2020-01-14
2271331538684923K181260MiiS Horus Scope DPT 100HKX2019-06-21
1321311538684923K181260MiiS Horus Scope DPT 100HKX2019-06-21
2271331465292767K170470Digital Eye Anterior CameraHJO2017-10-06
1321311465292767K170470Digital Eye Anterior CameraHJO2017-10-06
1321311537428550K120982DIGITAL EYE-FUNDUS CAMERAHKI2012-09-28
2271331537428550K120982DIGITAL EYE-FUNDUS CAMERAHKI2012-09-28
1321311221226718
1321311224333167
1321311288812525
1321311600483735
1321311643726441
1321311785848475
1321311810033762
1321311913227965
1321311919877933
1321311979522957
2271331221226718
2271331224333167
2271331288812525
2271331349856203
2271331443778242
2271331530385511
2271331600483735
2271331643726441
2271331723101248
2271331785848475
2271331810033762
2271331913227965
2271331919877933
2271331979522957

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKX32023-11-08
HJO32020-01-14
HKI22012-09-28
HRX12025-12-23
EOQ12024-05-01
FAJ12023-10-06
EOB12022-07-01

PMN#

GUDID#

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 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 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 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 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 - 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 - 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 - 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

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.

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 – 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™ - 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 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 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 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