The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Gyroscan T10-nt (release 4 Series Software).
| Device ID | K940534 |
| 510k Number | K940534 |
| Device Name: | GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 -4708 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 -4708 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-11-22 |