The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Modification To: Sens-a-ray System With Proimage Software.
| Device ID | K013176 |
| 510k Number | K013176 |
| Device Name: | MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE |
| Classification | Unit, X-ray, Extraoral With Timer |
| 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 | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-24 |
| Decision Date | 2001-10-16 |
| Summary: | summary |