The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Image X-70 Plus Dental X-ray Unit.
| Device ID | K000551 |
| 510k Number | K000551 |
| Device Name: | IMAGE X-70 PLUS DENTAL X-RAY UNIT |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-18 |
| Decision Date | 2000-03-16 |