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FDA 510(k)

C-IOO MOBILE CINE CT UNIT

K-Number: K864046 · 1986-11-10

ApplicantImatron, Inc.
Decision Date1986-11-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C-IOO MOBILE CINE CT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Imatron, Inc.. It received FDA 510(k) clearance on 1986-11-10 under 510(k) number K864046. 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-IOO MOBILE CINE CT UNIT?

C-IOO MOBILE CINE CT UNIT is a medical device that received FDA 510(k) clearance on 1986-11-10. The listed applicant is Imatron, Inc.. The 510(k) number is K864046.

When did C-IOO MOBILE CINE CT UNIT receive FDA 510(k) clearance?

C-IOO MOBILE CINE CT UNIT received FDA 510(k) clearance on 1986-11-10, under 510(k) number K864046.

Who is the listed applicant for C-IOO MOBILE CINE CT UNIT?

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-IOO MOBILE CINE CT UNIT?

The FDA product code for C-IOO MOBILE CINE CT UNIT 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, EVOLUTIONK913352C-150 ULTRAFAST CT SCANNER

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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