FDA 510(k)

Vaginal Tactile Ultrasound Imager

K-Number: K231875 · 2024-02-22

Decision Date2024-02-22

Product CodeHIR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Vaginal Tactile Ultrasound Imager is a medical device manufactured by Advanced Tactile Imaging, Inc.. It received FDA 510(k) clearance on 2024-02-22 under approval number K231875. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vaginal Tactile Ultrasound Imager?

Vaginal Tactile Ultrasound Imager is a medical device that received FDA 510(k) clearance on 2024-02-22. It is manufactured by Advanced Tactile Imaging, Inc.. The 510(k) number is K231875.

When was Vaginal Tactile Ultrasound Imager approved by the FDA?

Vaginal Tactile Ultrasound Imager received FDA 510(k) clearance on 2024-02-22, under approval number K231875.

What company makes Vaginal Tactile Ultrasound Imager?

Vaginal Tactile Ultrasound Imager is manufactured by Advanced Tactile Imaging, Inc..

What is the FDA product code for Vaginal Tactile Ultrasound Imager?

The FDA product code for Vaginal Tactile Ultrasound Imager is HIR.

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Official Source

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