The following data is part of a premarket notification filed by Xoran Technologies Llc with the FDA for Xoran Workstation, Model 10050.
| Device ID | K210257 |
| 510k Number | K210257 |
| Device Name: | Xoran Workstation, Model 10050 |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860290000391 | K210257 | 000 |
| 00860008443717 | K210257 | 000 |