K828669Substantially Equivalent

Computed Cinetomography Scanner, Model C-100

Name: K828669 Computed Cinetomography Scanner, Model C-100
Creator: Imatron, Inc.
Published: 1983-01-14
License: https://open.fda.gov/license/

Imatron, Inc., South San Fransisco CA / Traditional, Substantially Equivalent

FDA source

K828669 is the FDA 510(k) clearance record for COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100, cleared for Imatron, Inc. on 1983-01-14. FDA records list 11 510(k) clearances for Imatron, Inc., from 1983-01-14 to 2000-12-11. As of 2026-09-10, FDA records show no recalls naming K828669.

Clearance record

Decision date: 1983-01-14
Received: 1982-11-30 (45 days to decision)
Review panel: Unknown
Applicant: Imatron, Inc. 389 Oyster Pt. Blvd., South San Fransisco CA
Third party review: No