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
LMAClass II

Digitizer, Image, Radiological

21 CFR 892.2030 / Radiology
FDA source (opens on fda.gov)

LMA is the FDA product code for Digitizer, Image, Radiological, a class II device type, regulated under 21 CFR 892.2030. As of , FDA records hold 61 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LMA
Device name
Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
61
Ingested recalls
2

Clearances, product code LMA

By decision year
61 clearances under product code LMA with a decision year between 1985 and 2013, 1998 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LMA by decision year
YearClearances
19851
19871
19894
19903
19911
19921
19934
19943
19953
19964
19974
19987
19994
20005
20013
20023
20032
20041
20061
20091
20102
20133

Applicants with the most clearances

Product code LMA
Applicants holding the most 510(k) clearances under product code LMA
ApplicantClearances
Vidar Systems Corp.10
Lumisys, Inc.5
Eastman Kodak Company3
Howtek, Inc.3
Array Corp.2
dba Systems, Inc.2
General Scanning, Inc.2
Konica Medical Corp.2
Radiographic Digital Imaging, Inc.2
Adaptive Video, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code