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FDA 510(k)

NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)

K-Number: K130318 · 2013-04-22

ApplicantVarian Medical Systems, X-Ray Products-Infimed
Decision Date2013-04-22
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. It received FDA 510(k) clearance on 2013-04-22 under 510(k) number K130318. 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 NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)?

NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) is a medical device that received FDA 510(k) clearance on 2013-04-22. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. The 510(k) number is K130318.

When did NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) receive FDA 510(k) clearance?

NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) received FDA 510(k) clearance on 2013-04-22, under 510(k) number K130318.

Who is the listed applicant for NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)?

The FDA 510(k) record lists Varian Medical Systems, X-Ray Products-Infimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)?

The FDA product code for NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) is JAA.

Related Clinical Trials

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Other records listing Varian Medical Systems, X-Ray Products-Infimed 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.

K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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