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
K953964Substantially Equivalent

Lumisys, Lumiscan 20

Lumisys, Inc., San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953964 is the FDA 510(k) clearance record for LUMISYS, LUMISCAN 20, a class II device, cleared for Lumisys, Inc. on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list 7 510(k) clearances for Lumisys, Inc., from to . As of , FDA records show no recalls naming K953964.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Lumisys, Inc. 16303 Panoramic Way, San Leandro CA
510(k) summary
Summary
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