The following data is part of a premarket notification filed by Faxitron Bioptics Llc with the FDA for Faxitron Specien Radiography System.
| Device ID | K122428 |
| 510k Number | K122428 |
| Device Name: | FAXITRON SPECIEN RADIOGRAPHY SYSTEM |
| Classification | Cabinet, X-ray System |
| Applicant | FAXITRON BIOPTICS LLC 3440 E. BRITANNIA DRIVE SUITE 150 Tucson, AZ 85706 |
| Contact | Douglas C Wiegman |
| Correspondent | Douglas C Wiegman FAXITRON BIOPTICS LLC 3440 E. BRITANNIA DRIVE 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 | 2012-08-09 |
| Decision Date | 2012-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857069006050 | K122428 | 000 |
| 00857069006289 | K122428 | 000 |
| 15420045515031 | K122428 | 000 |
| 15420045514836 | K122428 | 000 |