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FDA 510(k)

CIRAS ULTRASONIC SCANNING SYSTEM

K-Number: K811633 · 1981-07-10

ApplicantAusonics Pty , Ltd.
Decision Date1981-07-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CIRAS ULTRASONIC SCANNING SYSTEM 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 1981-07-10 under 510(k) number K811633. 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 CIRAS ULTRASONIC SCANNING SYSTEM?

CIRAS ULTRASONIC SCANNING SYSTEM is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K811633.

When did CIRAS ULTRASONIC SCANNING SYSTEM receive FDA 510(k) clearance?

CIRAS ULTRASONIC SCANNING SYSTEM received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811633.

Who is the listed applicant for CIRAS ULTRASONIC SCANNING SYSTEM?

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 CIRAS ULTRASONIC SCANNING SYSTEM?

The FDA product code for CIRAS ULTRASONIC SCANNING SYSTEM 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 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: 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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