Cleared Traditional

K923533 - ADMARK

K923533 is an FDA 510(k) clearance for ADMARK, manufactured by Planmeca USA, Inc.. The device is a Class 1 Radiology device with product code JAC cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K923533 · Planmeca USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
231d
Days
Class 1
Risk

K923533 is an FDA 510(k) clearance for the ADMARK. Classified as System, X-ray, Film Marking, Radiographic (product code JAC), Class I - General Controls.

Submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on March 4, 1993 after a review of 231 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1640 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Planmeca USA, Inc. devices

FDA 510(k) Submission Details - K923533

510(k) Number K923533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 107d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

JAC Device Classification - Class 1, General Controls

Product Code JAC System, X-ray, Film Marking, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JAC System, X-ray, Film Marking, Radiographic

All 10
Devices cleared under the same product code (JAC) and FDA review panel - the closest regulatory comparables to K923533.
FUJI EC ID CAMERA
K932357 · Fujifilm Medical System U.S.A., Inc. · Jul 1993
KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L
K926404 · Eastman Kodak Company · Mar 1993
RADIOGRAPHIC FILM MARKETING SYSTEM
K924345 · Fischer Imaging Corp. · Nov 1992
KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE
K920031 · Eastman Kodak Company · Feb 1992
KODAK MIN-R IDENTIFICATION CAMERA
K915088 · Eastman Kodak Company · Dec 1991
DU PONT IDENTIFICATION CAMERA
K910354 · Dupont Medical Products · Mar 1991