510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K132183Substantially Equivalent

Dicom Video

Bar Code Computer, Ltd., Haifa, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132183 is the FDA 510(k) clearance record for DICOM VIDEO, a class II device, cleared for Bar Code Computer, Ltd. on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list one 510(k) clearance for Bar Code Computer, Ltd. As of , FDA records show no recalls naming K132183.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Bar Code Computer, Ltd. 6 Sireni, Haifa, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LMA

Trailing 12 months

FDA records hold no clearances under product code LMA in the trailing twelve months.

FDA records show no clearances under product code LMA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260