The following data is part of a premarket notification filed by Visual Medica with the FDA for Vm Pacs With Vm Medical Workstation.
| Device ID | K141561 |
| 510k Number | K141561 |
| Device Name: | VM PACS WITH VM MEDICAL WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | VISUAL MEDICA ECUADOR 1465 1 D Ciudad Autonoma De Buenos Aires, AR Cp 1425 |
| Contact | Melissa Llabres Grau |
| Correspondent | Melissa Llabres Grau VISUAL MEDICA ECUADOR 1465 1 D Ciudad Autonoma De Buenos Aires, AR Cp 1425 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2015-01-16 |
| Summary: | summary |