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FDA 510(k)

X-RAY IMAGE INTENSIFIER PRODUCTS

K-Number: K810716 · 1981-04-23

ApplicantInstrumentation Camera, Inc.
Decision Date1981-04-23
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY IMAGE INTENSIFIER PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Camera, Inc.. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810716. 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 X-RAY IMAGE INTENSIFIER PRODUCTS?

X-RAY IMAGE INTENSIFIER PRODUCTS is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Instrumentation Camera, Inc.. The 510(k) number is K810716.

When did X-RAY IMAGE INTENSIFIER PRODUCTS receive FDA 510(k) clearance?

X-RAY IMAGE INTENSIFIER PRODUCTS received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810716.

Who is the listed applicant for X-RAY IMAGE INTENSIFIER PRODUCTS?

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

What is the FDA product code for X-RAY IMAGE INTENSIFIER PRODUCTS?

The FDA product code for X-RAY IMAGE INTENSIFIER PRODUCTS is JAA.

Related Clinical Trials

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Other records listing Instrumentation Camera, 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.

K802132105MM SPOT FILM CAMERA

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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