FDA product code LMA: Digitizer, Image, Radiological
LMA is the FDA product code for digitizer, image, radiological. It is a Class II device, regulated under 21 CFR 892.2030 and reviewed by the Radiology panel. FDA has cleared 61 510(k) submissions under LMA, from 38 different applicants. The average 510(k) review took 115 days (median 85). FDA has posted 2 recalls for LMA devices.
Classification
| Field | Value |
|---|---|
| Device name | Digitizer, Image, Radiological |
| Device class | Class II |
| Regulation | 21 CFR 892.2030 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LMA clearance
Top LMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vidar Systems Corp. | 10 | 2013-06-07 |
| Lumisys, Inc. | 5 | 1998-05-11 |
| Array Corp. | 3 | 2006-12-21 |
| Howtek, Inc. | 3 | 2002-08-12 |
| Eastman Kodak Company | 3 | 1997-08-20 |
33 more applicants have LMA clearances. See the full list in Caduvo.
Most recent LMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132183 | Bar Code Computer, Ltd. | DICOM VIDEO | 2013-10-03 | 80 |
| K130636 | Vidar Systems Corp. | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | 2013-06-07 | 88 |
| K130406 | Vidar Systems Corp. | DIAGNOSTICPRO EDGE | 2013-04-29 | 69 |
| K102476 | Vidar Systems Corp. | TELERADPRO | 2010-10-07 | 38 |
| K093809 | Vidar Systems Corp. | VIDAR DENTAL FILM DIGITIZER | 2010-01-07 | 29 |
Recalls for LMA devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-25.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code LMA?
LMA is the FDA product code for digitizer, image, radiological. It is a Class II device, regulated under 21 CFR 892.2030 and reviewed by the Radiology panel.
What device class is LMA?
Class II, regulation 21 CFR 892.2030. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LMA?
Across 61 cleared submissions the average was 115 days from receipt to decision (median 85).
Which companies have the most LMA clearances?
Vidar Systems Corp. (10); Lumisys, Inc. (5); Array Corp. (3); Howtek, Inc. (3); Eastman Kodak Company (3).
Have LMA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code LMA
- Run a recall and safety report across every LMA manufacturer
- Watch product code LMA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times