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FDA 510(k)

FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.

K-Number: K770337 · 1977-03-01

ApplicantLitton Medical Systems
Decision Date1977-03-01
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. is the device name listed in this FDA 510(k) record. The listed applicant is Litton Medical Systems. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K770337. 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 FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.?

FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is Litton Medical Systems. The 510(k) number is K770337.

When did FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. receive FDA 510(k) clearance?

FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. received FDA 510(k) clearance on 1977-03-01, under 510(k) number K770337.

Who is the listed applicant for FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.?

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

What is the FDA product code for FLUOROSCOPIC ASSEMBLY, IMAGE INTENS.?

The FDA product code for FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. is JAA.

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Other records listing Litton Medical Systems 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.

K770334TILTING X-RAY TABLEK770336X-RAY TUBE, ROTATING ANODEK770338X-RAY CONTROL & X-RAY HV GENERATORK770333FLUOROSCOPE, C-ARMK770335COLLIMATOR, AUTOMATICK760569THREE PHASE X-RAY CONTROLS & HV GENERATORS

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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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