Cleared Traditional

K910092 - 3M LASER IMAGER XL

K910092 is an FDA 510(k) clearance for 3M LASER IMAGER XL, 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 89-day FDA review.

K910092 · 3M Medical Products Group · Radiology device
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Apr 1991
Decision
89d
Days
Class 2
Risk

K910092 is an FDA 510(k) clearance for the 3M LASER IMAGER XL. 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 April 8, 1991 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Medical Products Group devices

FDA 510(k) Submission Details - K910092

510(k) Number K910092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date April 08, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 107d · This submission: 89d
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 K910092.
KODAK EKTASCAN 1120 LASER PRINTER
K914582 · Eastman Kodak Company · Dec 1991
EAGLE SYSTEM
K912799 · Marquette Electronics, Inc. · Dec 1991
KODAK EKTASCAN CABLE EXTENSION
K911437 · Eastman Kodak Company · May 1991
KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS
K905566 · Eastman Kodak Company · Jan 1991
FUJI MEDICAL LASER IMAGER
K900885 · Fujifilm Medical System U.S.A., Inc. · Mar 1990
DIGICAM LHP (VIDEO INTERFACE OPTION)
K895668 · Siemens Gammasonics, Inc. · Nov 1989