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FDA 510(k)

SYSTEM, X-RAY, MAMOGRAPHIC

K-Number: K936161 · 1994-05-04

ApplicantTechnowipe
Decision Date1994-05-04
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYSTEM, X-RAY, MAMOGRAPHIC is the device name listed in this FDA 510(k) record. The listed applicant is Technowipe. It received FDA 510(k) clearance on 1994-05-04 under 510(k) number K936161. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM, X-RAY, MAMOGRAPHIC?

SYSTEM, X-RAY, MAMOGRAPHIC is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Technowipe. The 510(k) number is K936161.

When did SYSTEM, X-RAY, MAMOGRAPHIC receive FDA 510(k) clearance?

SYSTEM, X-RAY, MAMOGRAPHIC received FDA 510(k) clearance on 1994-05-04, under 510(k) number K936161.

Who is the listed applicant for SYSTEM, X-RAY, MAMOGRAPHIC?

The FDA 510(k) record lists Technowipe as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM, X-RAY, MAMOGRAPHIC?

The FDA product code for SYSTEM, X-RAY, MAMOGRAPHIC is IZH.

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Related Devices (Code: IZH)

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.

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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.

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