The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Picker Mr Workstations (vistar,montage And Oncall).
| Device ID | K961637 |
| 510k Number | K961637 |
| Device Name: | PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL) |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Contact | Elaine K Keeler, Ph.d. |
| Correspondent | Elaine K Keeler, Ph.d. PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-29 |
| Decision Date | 1996-07-03 |
| Summary: | summary |