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FDA 510(k)

PI808 MOBILE C-ARM IMAGE INTENSIFIER

K-Number: K820178 · 1982-03-04

ApplicantPrecise Optics
Decision Date1982-03-04
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PI808 MOBILE C-ARM IMAGE INTENSIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Precise Optics. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K820178. 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 PI808 MOBILE C-ARM IMAGE INTENSIFIER?

PI808 MOBILE C-ARM IMAGE INTENSIFIER is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Precise Optics. The 510(k) number is K820178.

When did PI808 MOBILE C-ARM IMAGE INTENSIFIER receive FDA 510(k) clearance?

PI808 MOBILE C-ARM IMAGE INTENSIFIER received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820178.

Who is the listed applicant for PI808 MOBILE C-ARM IMAGE INTENSIFIER?

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

What is the FDA product code for PI808 MOBILE C-ARM IMAGE INTENSIFIER?

The FDA product code for PI808 MOBILE C-ARM IMAGE INTENSIFIER is JAA.

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Other records listing Precise Optics 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.

K030061PS 3000 DIGATAL PHOTOSPOT SYSTEMK935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIERK932878PRECISION INTRA-ORAL SCOPESK914084ENDOSCOPESK914184P2020-8-0 BEAM-LIMITING DEVICEK911744PRECISION OPTICS CORPORATION LAPAROSCOPE

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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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