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FDA 510(k)

COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100

K-Number: K828669 · 1983-01-14

ApplicantImatron, Inc.
Decision Date1983-01-14
Product Code
DecisionSubstantially Equivalent

Device Summary

COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 is the device name listed in this FDA 510(k) record. The listed applicant is Imatron, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K828669. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100?

COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Imatron, Inc.. The 510(k) number is K828669.

When did COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 receive FDA 510(k) clearance?

COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 received FDA 510(k) clearance on 1983-01-14, under 510(k) number K828669.

Who is the listed applicant for COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100?

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

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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 →

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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