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FDA 510(k)

DRF 4343

K-Number: K080859 · 2008-06-04

ApplicantVilla Sistemi Medicali S.P.A.
Decision Date2008-06-04
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRF 4343 is the device name listed in this FDA 510(k) record. The listed applicant is Villa Sistemi Medicali S.P.A.. It received FDA 510(k) clearance on 2008-06-04 under 510(k) number K080859. 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 DRF 4343?

DRF 4343 is a medical device that received FDA 510(k) clearance on 2008-06-04. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K080859.

When did DRF 4343 receive FDA 510(k) clearance?

DRF 4343 received FDA 510(k) clearance on 2008-06-04, under 510(k) number K080859.

Who is the listed applicant for DRF 4343?

The FDA 510(k) record lists Villa Sistemi Medicali S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRF 4343?

The FDA product code for DRF 4343 is JAA.

Other records listing Villa Sistemi Medicali S.P.A. 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.

K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)K130109ENDOGRAPH DCK111152ROTOGRAPH EVO 3DK090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191K050190APOLLO

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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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