FDA product code LMC: Camera, Multi Format, Radiological
LMC is the FDA product code for camera, multi format, radiological. It is a Class II device, regulated under 21 CFR 892.2040 and reviewed by the Radiology panel. FDA has cleared 121 510(k) submissions under LMC, from 58 different applicants. The average 510(k) review took 90 days (median 74). FDA has posted 3 recalls for LMC devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Multi Format, Radiological |
| Device class | Class II |
| Regulation | 21 CFR 892.2040 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LMC clearance
Top LMC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 14 | 2004-09-24 |
| International Imaging Electronics | 13 | 1996-05-07 |
| Fujifilm Medical System U.S.A., Inc. | 7 | 2004-01-09 |
| Codonics, Inc. | 6 | 2006-03-16 |
| Agfa Corp. | 5 | 2003-09-24 |
53 more applicants have LMC clearances. See the full list in Caduvo.
Most recent LMC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141454 | Sony Electronics, Inc. | SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD | 2014-06-26 | 24 |
| K141346 | Sony Electronics, Inc. | SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD | 2014-06-26 | 35 |
| K111566 | Carestream Health, Inc. | DRYVIEW CHROMA IMAGING SYSTEM | 2011-10-06 | 122 |
| K092280 | Virtual Imaging, Inc. | CYPHER DICOM PRINT SOLUTION | 2009-10-16 | 80 |
| K090469 | Carestream Health, Inc. | CARESTREAM DRYVIEW 5850 LASER IMAGER | 2009-05-22 | 88 |
Recalls for LMC devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-11.
Frequently asked questions
What is FDA product code LMC?
LMC is the FDA product code for camera, multi format, radiological. It is a Class II device, regulated under 21 CFR 892.2040 and reviewed by the Radiology panel.
What device class is LMC?
Class II, regulation 21 CFR 892.2040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LMC?
Across 121 cleared submissions the average was 90 days from receipt to decision (median 74).
Which companies have the most LMC clearances?
Eastman Kodak Company (14); International Imaging Electronics (13); Fujifilm Medical System U.S.A., Inc. (7); Codonics, Inc. (6); Agfa Corp. (5).
Have LMC devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2015-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LMC
- Run a recall and safety report across every LMC manufacturer
- Watch product code LMC 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.
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