The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Gyroscan Intera 3.0t.
Device ID | K003516 |
510k Number | K003516 |
Device Name: | GYROSCAN INTERA 3.0T |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | Peter Altman |
Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. 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 | 2000-11-14 |
Decision Date | 2000-12-27 |