The following data is part of a premarket notification filed by Medasys, Inc. with the FDA for Pinnacle Image Processing System.
| Device ID | K902648 |
| 510k Number | K902648 |
| Device Name: | PINNACLE IMAGE PROCESSING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDASYS, INC. 4651 PLATT RD. Ann Arbor, MI 48108 |
| Contact | Robert R Laskowski |
| Correspondent | Robert R Laskowski MEDASYS, INC. 4651 PLATT RD. Ann Arbor, MI 48108 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-15 |
| Decision Date | 1990-08-17 |