The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Ct Guide (tm).
| Device ID | K903622 |
| 510k Number | K903622 |
| Device Name: | CT GUIDE (TM) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Dusan Kolar |
| Correspondent | Dusan Kolar RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-09 |
| Decision Date | 1990-10-29 |