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FDA 510(k)

PET-TV X-RAY IMAGE INTENSIFIER SYSTEM

K-Number: K771485 · 1977-08-16

ApplicantDiagnostic Information, Inc.
Decision Date1977-08-16
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PET-TV X-RAY IMAGE INTENSIFIER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Information, Inc.. It received FDA 510(k) clearance on 1977-08-16 under 510(k) number K771485. 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 PET-TV X-RAY IMAGE INTENSIFIER SYSTEM?

PET-TV X-RAY IMAGE INTENSIFIER SYSTEM is a medical device that received FDA 510(k) clearance on 1977-08-16. The listed applicant is Diagnostic Information, Inc.. The 510(k) number is K771485.

When did PET-TV X-RAY IMAGE INTENSIFIER SYSTEM receive FDA 510(k) clearance?

PET-TV X-RAY IMAGE INTENSIFIER SYSTEM received FDA 510(k) clearance on 1977-08-16, under 510(k) number K771485.

Who is the listed applicant for PET-TV X-RAY IMAGE INTENSIFIER SYSTEM?

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

What is the FDA product code for PET-TV X-RAY IMAGE INTENSIFIER SYSTEM?

The FDA product code for PET-TV X-RAY IMAGE INTENSIFIER 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 Diagnostic Information, 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.

K801166PET-SCOPE II MODEL DIS-1611K761285PET-SCOPE

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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