Cleared Traditional

K972660 - RAVEN DRY PRINTER

K972660 is an FDA 510(k) clearance for RAVEN DRY PRINTER, manufactured by Sterling Diagnostic Imaging, Inc.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K972660 · Sterling Diagnostic Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
117d
Days
Class 2
Risk

K972660 is an FDA 510(k) clearance for the RAVEN DRY PRINTER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Sterling Diagnostic Imaging, Inc. (Newark, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 117 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 Sterling Diagnostic Imaging, Inc. devices

FDA 510(k) Submission Details - K972660

510(k) Number K972660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1997
Decision Date November 10, 1997
Days to Decision 117 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
10d slower than avg
Panel avg: 107d · This submission: 117d
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 K972660.
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
K002146 · Eastman Kodak Company · Sep 2000
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
K983905 · Eastman Kodak Company · Jan 1999
IMATION SE-204 LASER IMAGER
K972822 · Imation Enterprises Corp. · Nov 1997
HELIOS LASER IMAGER 1417
K973028 · Sterling Diagnostic Imaging, Inc. · Oct 1997
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
K973422 · Dejarnette Research Systems · Oct 1997
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
K972847 · Eastman Kodak Company · Oct 1997