Cleared Traditional

K923222 - 3M COLOR LASER IMAGER

K923222 is an FDA 510(k) clearance for 3M COLOR LASER IMAGER, manufactured by 3M Medical Products Group. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K923222 · 3M Medical Products Group · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
91d
Days
Class 2
Risk

K923222 is an FDA 510(k) clearance for the 3M COLOR LASER IMAGER, MODEL 979. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by 3M Medical Products Group (St Paul, US). The FDA issued a Cleared decision on September 30, 1992 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 3M Medical Products Group devices

FDA 510(k) Submission Details - K923222

510(k) Number K923222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date September 30, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMC Device Classification - Class 2, Special Controls

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LMC Camera, Multi Format, Radiological

All 38
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K923222.
PMI100 VIDEO IMAGER
K925220 · Heraeus Kulzer, Inc. · May 1993
PHILIPS LASER DISK ARCHIVE
K923481 · Philips Medical Systems, Inc. · May 1993
MATRIX CR 2050, PMI 3000
K925289 · Heraeus Kulzer, Inc. · Apr 1993
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
K922411 · Eastman Kodak Company · Aug 1992
KODAK EKTASCAN 2180 LASER PRINTER
K921743 · Eastman Kodak Company · Jul 1992
KODAK EKTASCAN 1120 LASER PRINTER
K914582 · Eastman Kodak Company · Dec 1991