The following data is part of a premarket notification filed by Faxitron Bioptics Llc with the FDA for Pathvisionxl.
| Device ID | K183142 |
| 510k Number | K183142 |
| Device Name: | PathVisionXL |
| Classification | Cabinet, X-ray System |
| Applicant | Faxitron Bioptics LLC 3440 E. Britannia Dr., Suite 150 Tucson, AZ 85706 |
| Contact | Ciaran Purdy |
| Correspondent | Ciaran Purdy 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 | 2018-11-13 |
| Decision Date | 2019-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045514928 | K183142 | 000 |