Cleared Traditional

K042133 - DRY LASER IMAGER, MODEL DRYPRO MODEL 793

K042133 is an FDA 510(k) clearance for DRY LASER IMAGER, manufactured by Konica Minolta Medical & Graphic, Inc.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K042133 · Konica Minolta Medical & Graphic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
107d
Days
Class 2
Risk

K042133 is an FDA 510(k) clearance for the DRY LASER IMAGER, MODEL DRYPRO MODEL 793. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Konica Minolta Medical & Graphic, Inc. (Watarai-Gun; Mie-Ken, JP). The FDA issued a Cleared decision on November 24, 2004 after a review of 107 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 Konica Minolta Medical & Graphic, Inc. devices

FDA 510(k) Submission Details - K042133

510(k) Number K042133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2004
Decision Date November 24, 2004
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
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 75
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K042133.
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU
K061302 · Mitsubishi Electric Corporation Kyoto Works · Jun 2006
CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER
K060440 · Codonics, Inc. · Mar 2006
DRYSTAR MODEL 5500
K052251 · Agfa Corporation · Aug 2005
NP-2600 SERIES HARDCOPY PRINTERS
K042232 · Codonics, Inc. · Oct 2004
KODAK MEDICAL IMAGER 300
K042158 · Eastman Kodak Company · Sep 2004
KODAK COLOR MEDICAL IMAGER 1000
K042159 · Eastman Kodak Company · Sep 2004