Data / Medical devices / Digitizer, Image, Radiological
Digitizer, Image, Radiological (LMA): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Digitizer, Image, Radiological (product code LMA, Class 2, 21 CFR 892.2030). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 61 510(k) clearances under this code, the latest on October 3, 2013, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LMA
- Device class
- 2
- Regulation
- 892.2030
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 1 |
| India | 1 |
| Taiwan | 1 |
Makers of Digitizer, Image, Radiological
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hyland Software, Inc. | Auburn, CA, United States | Manufacturer | 1 | October 20, 2004 | 0 | 0 | 0 | api.fda.gov |
| Icad Inc. | Nashua, NH, United States | Manufacturer | 1 | May 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Microtek Computer Technology (Wu Jiang) Co, Ltd. | SuZhou Jiangsu, China | Manufacturer | 1 | August 14, 2009 | 0 | 0 | 0 | api.fda.gov |
| iCRco Inc. | Goleta, CA, United States | Manufacturer | 1 | October 11, 2002 | 0 | 0 | 0 | api.fda.gov |
| Ambalsoft Infotech Private Ltd | Chennai Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yankang Medical Instrument Co., Ltd. | Taipei, Taiwan | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 3, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.