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FDA 510(k)

DUET DRF

K-Number: K103038 · 2011-03-29

ApplicantCmt Medical Technologies, Ltd.
Decision Date2011-03-29
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUET DRF is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2011-03-29 under 510(k) number K103038. 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 DUET DRF?

DUET DRF is a medical device that received FDA 510(k) clearance on 2011-03-29. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K103038.

When did DUET DRF receive FDA 510(k) clearance?

DUET DRF received FDA 510(k) clearance on 2011-03-29, under 510(k) number K103038.

Who is the listed applicant for DUET DRF?

The FDA 510(k) record lists Cmt Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUET DRF?

The FDA product code for DUET DRF is JAA.

Other records listing Cmt Medical Technologies, Ltd. as applicant

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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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