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FDA 510(k)

X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC

K-Number: K770693 · 1977-08-03

ApplicantXonics Medical Systems, Inc.
Decision Date1977-08-03
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC is the device name listed in this FDA 510(k) record. The listed applicant is Xonics Medical Systems, Inc.. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K770693. 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 X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC?

X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Xonics Medical Systems, Inc.. The 510(k) number is K770693.

When did X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC receive FDA 510(k) clearance?

X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC received FDA 510(k) clearance on 1977-08-03, under 510(k) number K770693.

Who is the listed applicant for X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC?

The FDA 510(k) record lists Xonics Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC?

The FDA product code for X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC is IZH.

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Other records listing Xonics Medical Systems, Inc. as applicant

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.

K827292MODEL IC 3000K820593ESP SERIES (X-RAY GENERATORSK791298DIAGNOSTIC ULTRASOUND SYSTEM

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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