Cleared Traditional

K973422 - LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])

K973422 is an FDA 510(k) clearance for LASERSHARE PRINT SPOOLER(2100[SOLARIS X..., manufactured by Dejarnette Research Systems. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K973422 · Dejarnette Research Systems · Radiology device
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Oct 1997
Decision
48d
Days
Class 2
Risk

K973422 is an FDA 510(k) clearance for the LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]). Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Dejarnette Research Systems (Towson, US). The FDA issued a Cleared decision on October 28, 1997 after a review of 48 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 Dejarnette Research Systems devices

FDA 510(k) Submission Details - K973422

510(k) Number K973422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1997
Decision Date October 28, 1997
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
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 62
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K973422.
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HELIOS LASER IMAGER 1417
K973028 · Sterling Diagnostic Imaging, Inc. · Oct 1997
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
K972847 · Eastman Kodak Company · Oct 1997
COLORPOINT OR PROFESSIONAL COLORPOINT
K971760 · Seiko Instruments USA, Inc. · Oct 1997
IMATION SE-196 LASER IMAGER
K972163 · Imation Corp. · Sep 1997