The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Newtom Vg Computed Tomography X-ray System.
| Device ID | K072357 |
| 510k Number | K072357 |
| Device Name: | NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | AFP IMAGING CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane AFP IMAGING CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-22 |
| Decision Date | 2007-09-18 |
| Summary: | summary |