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FDA 510(k)

PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM

K-Number: K033326 · 2003-10-29

ApplicantPhilips Medical Systems, Inc.
Decision Date2003-10-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-10-29 under 510(k) number K033326. 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 PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM?

PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Philips Medical Systems, Inc.. The 510(k) number is K033326.

When did PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM receive FDA 510(k) clearance?

PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM received FDA 510(k) clearance on 2003-10-29, under 510(k) number K033326.

Who is the listed applicant for PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM?

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

What is the FDA product code for PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM?

The FDA product code for PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM is JAK.

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Other records listing Philips Medical Systems, 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.

K093355PCR ELEVA 1.2K090808PINNACLE3 SMARTARCK071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132AK041741M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENK040955M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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