The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Intera I/t.
| Device ID | K013344 |
| 510k Number | K013344 |
| Device Name: | INTERA I/T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 472 WHEELERS FARMS RD. Milford, CT 06460 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 472 WHEELERS FARMS RD. Milford, CT 06460 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-09 |
| Decision Date | 2001-12-11 |
| Summary: | summary |