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FDA 510(k)

ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION

K-Number: K972879 · 1997-10-15

ApplicantImatron, Inc.
Decision Date1997-10-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Imatron, Inc.. It received FDA 510(k) clearance on 1997-10-15 under 510(k) number K972879. 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 ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION?

ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION is a medical device that received FDA 510(k) clearance on 1997-10-15. The listed applicant is Imatron, Inc.. The 510(k) number is K972879.

When did ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION receive FDA 510(k) clearance?

ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION received FDA 510(k) clearance on 1997-10-15, under 510(k) number K972879.

Who is the listed applicant for ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION?

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 ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION?

The FDA product code for ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION 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 EXTENSIONSK913352C-150 ULTRAFAST CT SCANNERK874934UNIVERSAL 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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