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FDA 510(k)

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

K-Number: K223926 · 2023-10-06

ApplicantMedimaging Integrated Solution, Inc (Miis)
Decision Date2023-10-06
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is a medical device manufactured by Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2023-10-06 under approval number K223926. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K223926.

When was VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box approved by the FDA?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box received FDA 510(k) clearance on 2023-10-06, under approval number K223926.

What company makes VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is manufactured by Medimaging Integrated Solution, Inc (Miis).

What is the FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

The FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is FAJ.

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Other Devices by Medimaging Integrated Solution, Inc (Miis)

K170470Digital Eye Anterior Camera K181260MiiS Horus Scope DPT 100 K193188MiiS Horus Eye Anterior Camera K214050ENT Nasopharyngoscope and Accessories K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

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Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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