Cleared Traditional

ADMARK

K923533 · Planmeca USA, Inc. · Radiology
Mar 1993
Decision
231d
Days
Class 1
Risk

About This 510(k) Submission

K923533 is an FDA 510(k) clearance for the ADMARK, a System, X-ray, Film Marking, Radiographic (Class I — General Controls, product code JAC), submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on March 4, 1993, 231 days after receiving the submission on July 16, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1640.

Submission Details

510(k) Number K923533 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1992
Decision Date March 04, 1993
Days to Decision 231 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code JAC — System, X-ray, Film Marking, Radiographic
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1640

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