The following data is part of a premarket notification filed by Tractus Corporation with the FDA for Tractus Tissuemapper Reviewer Application.
| Device ID | K123901 |
| 510k Number | K123901 |
| Device Name: | TRACTUS TISSUEMAPPER REVIEWER APPLICATION |
| Classification | System, Image Processing, Radiological |
| Applicant | TRACTUS CORPORATION 981 EL CAJON DR. SUITE 100 Danville, CA 94526 |
| Contact | Eric Eggers |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-12-18 |
| Decision Date | 2013-01-29 |
| Summary: | summary |