The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Gyroscan T5-nt, Gyroscan T10-nt And Gyroscan Acs-nt Release 5 Series.
| Device ID | K963990 |
| 510k Number | K963990 |
| Device Name: | GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-04 |
| Decision Date | 1997-05-29 |
| Summary: | summary |