The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Sureview Mqsa Option Kits (model No.'s 377095 & 377096).
| Device ID | K944816 |
| 510k Number | K944816 |
| Device Name: | SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) |
| Classification | System, X-ray, Mammographic |
| 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 | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1995-02-08 |