The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Intuition - Tda, Tva, Parametric Mapping.
| Device ID | K131447 |
| 510k Number | K131447 |
| Device Name: | INTUITION - TDA, TVA, PARAMETRIC MAPPING |
| Classification | System, Image Processing, Radiological |
| Applicant | TERARECON, INC. 4000 E 3rd Ave Ste 200 Foster City, CA 94404 |
| Contact | Emilly T Nurthen |
| Correspondent | Emilly T Nurthen TERARECON, INC. 4000 E 3rd Ave Ste 200 Foster City, CA 94404 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2013-12-24 |
| Summary: | summary |