FDA 510(k)

ALPHA II DIAGNOSTIC X-RAY

K-Number: K864958 · 1987-01-30

Decision Date1987-01-30

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ALPHA II DIAGNOSTIC X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Ausonics Pty , Ltd.. It received FDA 510(k) clearance on 1987-01-30 under 510(k) number K864958. 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 ALPHA II DIAGNOSTIC X-RAY?

ALPHA II DIAGNOSTIC X-RAY is a medical device that received FDA 510(k) clearance on 1987-01-30. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K864958.

When did ALPHA II DIAGNOSTIC X-RAY receive FDA 510(k) clearance?

ALPHA II DIAGNOSTIC X-RAY received FDA 510(k) clearance on 1987-01-30, under 510(k) number K864958.

Who is the listed applicant for ALPHA II DIAGNOSTIC X-RAY?

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

What is the FDA product code for ALPHA II DIAGNOSTIC X-RAY?

The FDA product code for ALPHA II DIAGNOSTIC X-RAY is IZH.

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Other records listing Ausonics Pty , Ltd. as applicant

K933916AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER K915715CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER K920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION K905488DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN K9027287.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)K896714AUSONICS 5000

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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.