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FDA 510(k)

PQ5000 CT SYSTEM

K-Number: K943623 · 1995-04-27

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1995-04-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PQ5000 CT SYSTEM 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 1995-04-27 under 510(k) number K943623. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PQ5000 CT SYSTEM?

PQ5000 CT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-27. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K943623.

When did PQ5000 CT SYSTEM receive FDA 510(k) clearance?

PQ5000 CT SYSTEM received FDA 510(k) clearance on 1995-04-27, under 510(k) number K943623.

Who is the listed applicant for PQ5000 CT SYSTEM?

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 PQ5000 CT SYSTEM?

The FDA product code for PQ5000 CT SYSTEM is JAK.

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Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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