The following data is part of a premarket notification filed by Infomed Servicios Informaticos S.l. with the FDA for Ortomed.
| Device ID | K131348 | 
| 510k Number | K131348 | 
| Device Name: | ORTOMED | 
| Classification | System, Image Processing, Radiological | 
| Applicant | INFOMED SERVICIOS INFORMATICOS S.L. VIA AUGUSTA 158, 4TH FLOOR Barcelona, ES 08006 | 
| Contact | Santiago Sola | 
| Correspondent | Santiago Sola INFOMED SERVICIOS INFORMATICOS S.L. VIA AUGUSTA 158, 4TH FLOOR Barcelona, ES 08006 | 
| Product Code | LLZ | 
| CFR Regulation Number | 892.2050 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Abbreviated | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2013-05-10 | 
| Decision Date | 2014-08-05 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ORTOMED  79169412  4911603 Live/Registered | Infomed Servicios Informáticos, S.L. 2015-03-25 |