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FDA 510(k)

CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER

K-Number: K915715 · 1992-07-02

ApplicantAusonics Pty , Ltd.
Decision Date1992-07-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER 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 1992-07-02 under 510(k) number K915715. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER?

CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K915715.

When did CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER receive FDA 510(k) clearance?

CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER received FDA 510(k) clearance on 1992-07-02, under 510(k) number K915715.

Who is the listed applicant for CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER?

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 CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER?

The FDA product code for CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER is IYO.

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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 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 5000K881979RESUBMITTAL OF MI 1000C MICROIMAGER

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.

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