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FDA 510(k)

CT PERFUSION 4

K-Number: K052839 · 2006-03-10

ApplicantGE Healthcare
Decision Date2006-03-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT PERFUSION 4 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2006-03-10 under 510(k) number K052839. 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 CT PERFUSION 4?

CT PERFUSION 4 is a medical device that received FDA 510(k) clearance on 2006-03-10. The listed applicant is GE Healthcare. The 510(k) number is K052839.

When did CT PERFUSION 4 receive FDA 510(k) clearance?

CT PERFUSION 4 received FDA 510(k) clearance on 2006-03-10, under 510(k) number K052839.

Who is the listed applicant for CT PERFUSION 4?

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

What is the FDA product code for CT PERFUSION 4?

The FDA product code for CT PERFUSION 4 is JAK.

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Other records listing GE Healthcare 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.

K253639ViewK242925MR Contour DLK232346Digital Expert Access with Remote ScanningK223212Precision DLK221680Xeleris V Processing and Review SystemK221932Omni Legend

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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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