The following data is part of a premarket notification filed by Medx, Inc. with the FDA for D-scope Iii.
| Device ID | K884661 |
| 510k Number | K884661 |
| Device Name: | D-SCOPE III |
| Classification | Camera, Scintillation (gamma) |
| Applicant | MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
| Contact | J Frankel |
| Correspondent | J Frankel MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-04-12 |