Cleared Traditional

CAP-35B III/CINE 275

K971128 · Jamieson Film Co. · Radiology
Apr 1997
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K971128 is an FDA 510(k) clearance for the CAP-35B III/CINE 275, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by Jamieson Film Co. (Dallas, US). The FDA issued a Cleared decision on April 28, 1997, 32 days after receiving the submission on March 27, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K971128 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1997
Decision Date April 28, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXR — Table, Radiographic, Tilting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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