The following data is part of a premarket notification filed by Faxitron Bioptics Llc with the FDA for Faxitron Visionct.
| Device ID | K173309 |
| 510k Number | K173309 |
| Device Name: | Faxitron VisionCT |
| Classification | Cabinet, X-ray System |
| Applicant | Faxitron Bioptics Llc 3440 E. Britannia Dr. Suite 150 Tucson, AZ 85706 |
| Contact | Douglas C. Wiegman |
| Correspondent | Douglas C. Wiegman Faxitron Bioptics Llc 3440 E. Britannia Dr. Suite 150 Tucson, AZ 85706 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-18 |
| Decision Date | 2018-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857069006227 | K173309 | 000 |
| 15420045514911 | K173309 | 000 |