Cleared Traditional

K974315 - VIDAR VXR LS LASER FILM DIGITIZER

K974315 is an FDA 510(k) clearance for VIDAR VXR LS LASER FILM DIGITIZER, manufactured by Vidar Systems Corp.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K974315 · Vidar Systems Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
151d
Days
Class 2
Risk

K974315 is an FDA 510(k) clearance for the VIDAR VXR LS LASER FILM DIGITIZER. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Vidar Systems Corp. (Herndon, US). The FDA issued a Cleared decision on April 17, 1998 after a review of 151 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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.

FDA 510(k) Submission Details - K974315

510(k) Number K974315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date April 17, 1998
Days to Decision 151 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
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

All 56
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K974315.
FILM DIGITIZER MODEL 2905
K982785 · Array Corp. · Oct 1998
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873 · Konica Corp. · Jun 1998
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809 · Lumisys, Inc. · May 1998
LD2000 SERIES
K980565 · General Scanning, Inc. · Mar 1998
DI-2000
K980213 · Lumisys, Inc. · Mar 1998
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619 · Afp Imaging Corp. · Feb 1998
K974315 · VIDAR VXR LS LASER FILM DIGITIZER
Download PDF FDA Summary Vidar Systems Corp.