Cleared Traditional

K132183 - DICOM VIDEO

K132183 is an FDA 510(k) clearance for DICOM VIDEO, manufactured by Bar Code Computer, Ltd.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K132183 · Bar Code Computer, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
80d
Days
Class 2
Risk

K132183 is an FDA 510(k) clearance for the DICOM VIDEO. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Bar Code Computer, Ltd. (Haifa, IL). The FDA issued a Cleared decision on October 3, 2013 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K132183

510(k) Number K132183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date October 03, 2013
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
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
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K132183 · DICOM VIDEO
Download PDF FDA Summary Bar Code Computer, Lt…