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FDA 510(k)

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT

K-Number: K883372 · 1988-11-25

ApplicantAusonics Pty , Ltd.
Decision Date1988-11-25
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER 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 1988-11-25 under 510(k) number K883372. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT?

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT is a medical device that received FDA 510(k) clearance on 1988-11-25. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K883372.

When did ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT receive FDA 510(k) clearance?

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT received FDA 510(k) clearance on 1988-11-25, under 510(k) number K883372.

Who is the listed applicant for ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER 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 MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT?

The FDA product code for ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT is JAA.

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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: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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