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FDA 510(k)

C-150 ULTRAFAST CT SCANNER

K-Number: K913352 · 1991-11-29

ApplicantImatron, Inc.
Decision Date1991-11-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C-150 ULTRAFAST CT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Imatron, Inc.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K913352. 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 C-150 ULTRAFAST CT SCANNER?

C-150 ULTRAFAST CT SCANNER is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Imatron, Inc.. The 510(k) number is K913352.

When did C-150 ULTRAFAST CT SCANNER receive FDA 510(k) clearance?

C-150 ULTRAFAST CT SCANNER received FDA 510(k) clearance on 1991-11-29, under 510(k) number K913352.

Who is the listed applicant for C-150 ULTRAFAST CT SCANNER?

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

What is the FDA product code for C-150 ULTRAFAST CT SCANNER?

The FDA product code for C-150 ULTRAFAST CT SCANNER is JAK.

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Other records listing Imatron, 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.

K001550EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTRK000359EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTROK992740EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMSK972903IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONSK972879ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTIONK874934UNIVERSAL EXAMINATION TABLE

View all 11 devices →

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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