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FDA 510(k)

DIGITAL FLUORO STORE

K-Number: K923585 · 1992-10-21

ApplicantEigen
Decision Date1992-10-21
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL FLUORO STORE is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 1992-10-21 under 510(k) number K923585. 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 DIGITAL FLUORO STORE?

DIGITAL FLUORO STORE is a medical device that received FDA 510(k) clearance on 1992-10-21. The listed applicant is Eigen. The 510(k) number is K923585.

When did DIGITAL FLUORO STORE receive FDA 510(k) clearance?

DIGITAL FLUORO STORE received FDA 510(k) clearance on 1992-10-21, under 510(k) number K923585.

Who is the listed applicant for DIGITAL FLUORO STORE?

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

What is the FDA product code for DIGITAL FLUORO STORE?

The FDA product code for DIGITAL FLUORO STORE is JAA.

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Other records listing Eigen 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.

K222222Artemis, Artemis TPO, Artemis MXK173744ProFuse CADK162474ArtemisK063846EIGEN DSA 2000K933115DIGITAL DISK RECORDERK924164DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT

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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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