The following data is part of a premarket notification filed by Xoran Technologies Llc with the FDA for Minicat 2d.
| Device ID | K201825 |
| 510k Number | K201825 |
| Device Name: | MiniCAT 2D |
| Classification | System, X-ray, Stationary |
| Applicant | Xoran Technologies LLC 5210 S. State Rd. Ann Arbor, MI 48108 |
| Contact | Mark Mcgarrow |
| Correspondent | Mark Mcgarrow Xoran Technologies LLC 5210 S. State Rd. Ann Arbor, MI 48108 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2020-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860290000377 | K201825 | 000 |
| 00860008443724 | K201825 | 000 |
| 00860008443748 | K201825 | 000 |