The following data is part of a premarket notification filed by Medicrea International with the FDA for Unid Spine Analyzer.
| Device ID | K180091 |
| 510k Number | K180091 |
| Device Name: | UNiD Spine Analyzer |
| Classification | System, Image Processing, Radiological |
| Applicant | Medicrea International 5389 Route De Strasbourg- Vancia Rillieux La Pape, FR 69140 |
| Contact | David Ryan |
| Correspondent | David Ryan Medicrea International 5389 Route De Strasbourg- Vancia Rillieux La Pape, FR 69140 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-12 |
| Decision Date | 2018-02-08 |
| Summary: | summary |