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FDA 510(k)

IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

K-Number: K952456 · 1995-06-16

ApplicantFisher Imaging Corp.
Decision Date1995-06-16
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Imaging Corp.. It received FDA 510(k) clearance on 1995-06-16 under 510(k) number K952456. 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 IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM?

IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-16. The listed applicant is Fisher Imaging Corp.. The 510(k) number is K952456.

When did IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM receive FDA 510(k) clearance?

IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM received FDA 510(k) clearance on 1995-06-16, under 510(k) number K952456.

Who is the listed applicant for IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM?

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

What is the FDA product code for IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM?

The FDA product code for IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM 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 Fisher 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.

K870783BPA CARDIOVASCULAR PRESSURE AMPLIFIERK853652BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT

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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