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FDA 510(k)

PET-SCOPE II IMAGE INTENSIFIER

K-Number: K855213 · 1986-01-10

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1986-01-10
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PET-SCOPE II IMAGE INTENSIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1986-01-10 under 510(k) number K855213. 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 IMAGE INTENSIFIER?

PET-SCOPE II IMAGE INTENSIFIER is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K855213.

When did PET-SCOPE II IMAGE INTENSIFIER receive FDA 510(k) clearance?

PET-SCOPE II IMAGE INTENSIFIER received FDA 510(k) clearance on 1986-01-10, under 510(k) number K855213.

Who is the listed applicant for PET-SCOPE II IMAGE INTENSIFIER?

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

What is the FDA product code for PET-SCOPE II IMAGE INTENSIFIER?

The FDA product code for PET-SCOPE II IMAGE INTENSIFIER is JAA.

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Related Devices (Code: JAA)

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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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