Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

K-Number: K850173 · 1985-04-16

ApplicantAusonics Pty , Ltd.
Decision Date1985-04-16
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AUSONICS-ALPHA I 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 1985-04-16 under 510(k) number K850173. 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 AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT?

AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT is a medical device that received FDA 510(k) clearance on 1985-04-16. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K850173.

When did AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT receive FDA 510(k) clearance?

AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT received FDA 510(k) clearance on 1985-04-16, under 510(k) number K850173.

Who is the listed applicant for AUSONICS-ALPHA I 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 AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT?

The FDA product code for AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT is IZH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 27 devices →

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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.

↑