The following data is part of a premarket notification filed by Xoran Technologies, Inc. with the FDA for Xcat; Xcat For Neuro.
| Device ID | K061834 |
| 510k Number | K061834 |
| Device Name: | XCAT; XCAT FOR NEURO |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 -3301 |
| Contact | Jim Bertolina |
| Correspondent | Jim Bertolina XORAN TECHNOLOGIES, INC. 309 N. FIRST STREET Ann Arbor, MI 48103 -3301 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-29 |
| Decision Date | 2006-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860290000346 | K061834 | 000 |
| 00860290000339 | K061834 | 000 |
| 00860290000360 | K061834 | 000 |