The following data is part of a premarket notification filed by Olea Medical with the FDA for Perfscape V2.0.
| Device ID | K111161 |
| 510k Number | K111161 |
| Device Name: | PERFSCAPE V2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | OLEA MEDICAL 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Kristi Gusman |
| Correspondent | Kristi Gusman OLEA MEDICAL 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-04-25 |
| Decision Date | 2011-11-04 |
| Summary: | summary |