510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033637Substantially Equivalent

Medical Image Digitizer, Model 2908

Array Corp., Shibuya-Ku, Tokyo, JP / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K033637 is the FDA 510(k) clearance record for MEDICAL IMAGE DIGITIZER, MODEL 2908, a class II device, cleared for Array Corp. on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list one 510(k) clearance for Array Corp. As of , FDA records show no recalls naming K033637.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Array Corp. 3-42-10 Yoyogi, Shibuya-Ku, Tokyo, JP
510(k) summary
Statement
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