The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Epi-scope Option For Q Series Ct Systems.
| Device ID | K962010 |
| 510k Number | K962010 |
| Device Name: | EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143 |
| Contact | Robert L Turocy |
| Correspondent | Robert L Turocy PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. 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 | 1996-05-23 |
| Decision Date | 1997-03-21 |
| Summary: | summary |