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FDA 510(k)

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

K-Number: K863710 · 1986-10-14

ApplicantAusonics Pty , Ltd.
Decision Date1986-10-14
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT 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 1986-10-14 under 510(k) number K863710. 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 S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT?

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K863710.

When did ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT receive FDA 510(k) clearance?

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863710.

Who is the listed applicant for ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT?

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 S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT?

The FDA product code for ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT is IZH.

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Other records listing Ausonics Pty , Ltd. 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.

K933916AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNERK915715CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNERK920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTIONK905488DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCANK9027287.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)K896714AUSONICS 5000

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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

View on FDA Database →

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

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