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FDA 510(k)

MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM

K-Number: K884317 · 1988-12-20

ApplicantMedrad, Inc.
Decision Date1988-12-20
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1988-12-20 under 510(k) number K884317. 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 MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM?

MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1988-12-20. The listed applicant is Medrad, Inc.. The 510(k) number is K884317.

When did MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM receive FDA 510(k) clearance?

MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM received FDA 510(k) clearance on 1988-12-20, under 510(k) number K884317.

Who is the listed applicant for MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM?

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

What is the FDA product code for MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM?

The FDA product code for MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM is JAA.

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Other records listing Medrad, Inc. 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.

K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113363ANGIOJET SOLENT DISTA THROMBECTOMY SETK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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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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