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FDA 510(k)

DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)

K-Number: K942264 · 1994-07-20

ApplicantEigen Video
Decision Date1994-07-20
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) is the device name listed in this FDA 510(k) record. The listed applicant is Eigen Video. It received FDA 510(k) clearance on 1994-07-20 under 510(k) number K942264. 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 DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)?

DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) is a medical device that received FDA 510(k) clearance on 1994-07-20. The listed applicant is Eigen Video. The 510(k) number is K942264.

When did DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) receive FDA 510(k) clearance?

DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) received FDA 510(k) clearance on 1994-07-20, under 510(k) number K942264.

Who is the listed applicant for DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)?

The FDA 510(k) record lists Eigen Video as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)?

The FDA product code for DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) is JAA.

Related Clinical Trials

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.

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Other records listing Eigen Video 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.

K935026DIGITAL MEDIA CONVERTER (D-MC)K850080DIGITAL IMAGE PROCESSOR FP-2CK844375EIGEN FLORO-STOR FS-100

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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