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FDA 510(k)

Vaginal Tactile Ultrasound Imager

K-Number: K231875 · 2024-02-22

ApplicantAdvanced Tactile Imaging, Inc.
Decision Date2024-02-22
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Vaginal Tactile Ultrasound Imager is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Tactile Imaging, Inc.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) 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. The listed applicant is Advanced Tactile Imaging, Inc.. The 510(k) number is K231875.

When did Vaginal Tactile Ultrasound Imager receive FDA 510(k) clearance?

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

Who is the listed applicant for Vaginal Tactile Ultrasound Imager?

The FDA 510(k) record lists Advanced Tactile Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: HIR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 InnovationsK213913leva Pelvic Health SystemRenovia, Inc.

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.

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