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FDA 510(k)

EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER

K-Number: K926560 · 1994-05-09

ApplicantFischer Imaging Corp.
Decision Date1994-05-09
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Fischer Imaging Corp.. It received FDA 510(k) clearance on 1994-05-09 under 510(k) number K926560. 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 EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER?

EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER is a medical device that received FDA 510(k) clearance on 1994-05-09. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K926560.

When did EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER receive FDA 510(k) clearance?

EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER received FDA 510(k) clearance on 1994-05-09, under 510(k) number K926560.

Who is the listed applicant for EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER?

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

What is the FDA product code for EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER?

The FDA product code for EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER is JAA.

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Other records listing Fischer Imaging Corp. 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.

K042095MAMMOTESTK021113MAMMOPATHK981414LC POSITIONERK973400MAMMOTEST ADAPTER DRIVERK964806MD-1835K961207EP-X BIPLANE

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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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