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FDA 510(k)

EP-X BIPLANE

K-Number: K961207 · 1996-08-20

ApplicantFischer Imaging Corp.
Decision Date1996-08-20
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EP-X BIPLANE 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 1996-08-20 under 510(k) number K961207. 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 EP-X BIPLANE?

EP-X BIPLANE is a medical device that received FDA 510(k) clearance on 1996-08-20. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K961207.

When did EP-X BIPLANE receive FDA 510(k) clearance?

EP-X BIPLANE received FDA 510(k) clearance on 1996-08-20, under 510(k) number K961207.

Who is the listed applicant for EP-X BIPLANE?

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 EP-X BIPLANE?

The FDA product code for EP-X BIPLANE 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-1835K961022TANGENT VI TABLE

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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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