The following data is part of a premarket notification filed by Miles Inc., Agfa Division with the FDA for Di-2000.
| Device ID | K943602 |
| 510k Number | K943602 |
| Device Name: | DI-2000 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | MILES INC., AGFA DIVISION 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Contact | Michael Sullivan |
| Correspondent | Michael Sullivan MILES INC., AGFA DIVISION 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-25 |
| Decision Date | 1995-05-12 |