The following data is part of a premarket notification filed by Medx, Inc. with the FDA for Skan D-scope.
| Device ID | K870703 |
| 510k Number | K870703 |
| Device Name: | SKAN D-SCOPE |
| Classification | Camera, Scintillation (gamma) |
| Applicant | MEDX, INC. 925 A.E.C. DR. Wood Dale, IL 60191 |
| Contact | John M Holub |
| Correspondent | John M Holub MEDX, INC. 925 A.E.C. DR. Wood Dale, IL 60191 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-20 |
| Decision Date | 1987-02-26 |