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FDA 510(k)

PET-SCOPE II MODEL DIS-1611

K-Number: K801166 · 1980-06-26

ApplicantDiagnostic Information, Inc.
Decision Date1980-06-26
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PET-SCOPE II MODEL DIS-1611 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 1980-06-26 under 510(k) number K801166. 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-SCOPE II MODEL DIS-1611?

PET-SCOPE II MODEL DIS-1611 is a medical device that received FDA 510(k) clearance on 1980-06-26. The listed applicant is Diagnostic Information, Inc.. The 510(k) number is K801166.

When did PET-SCOPE II MODEL DIS-1611 receive FDA 510(k) clearance?

PET-SCOPE II MODEL DIS-1611 received FDA 510(k) clearance on 1980-06-26, under 510(k) number K801166.

Who is the listed applicant for PET-SCOPE II MODEL DIS-1611?

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-SCOPE II MODEL DIS-1611?

The FDA product code for PET-SCOPE II MODEL DIS-1611 is JAA.

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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.

K771485PET-TV X-RAY IMAGE INTENSIFIER SYSTEMK761285PET-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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