The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Scanaray/cd-dent Advanced Computerized X-ray System.
| Device ID | K974619 |
| 510k Number | K974619 |
| Device Name: | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM |
| Classification | Digitizer, Image, Radiological |
| 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 | LMA |
| CFR Regulation Number | 892.2030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-11 |
| Decision Date | 1998-02-25 |
| Summary: | summary |