The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Achieva 1.5t & Inera 1.5t Family.
| Device ID | K052013 |
| 510k Number | K052013 |
| Device Name: | ACHIEVA 1.5T & INERA 1.5T FAMILY |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY P.O. BOX 3003 Bothell, WA 98041 -8431 |
| Contact | Lynn T Harmer |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-07-26 |
| Decision Date | 2005-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970564410901 | K052013 | 000 |
| 06970564410499 | K052013 | 000 |
| 06970564410437 | K052013 | 000 |
| 06970564410420 | K052013 | 000 |
| 06970564410376 | K052013 | 000 |
| 06970564410369 | K052013 | 000 |
| 06970564410314 | K052013 | 000 |
| 06970564410307 | K052013 | 000 |
| 06970564410277 | K052013 | 000 |
| 06970564410260 | K052013 | 000 |
| 06970564410215 | K052013 | 000 |
| 06970564410154 | K052013 | 000 |
| 06970564410147 | K052013 | 000 |
| 06970564410116 | K052013 | 000 |
| 06970564410505 | K052013 | 000 |
| 06970564410550 | K052013 | 000 |
| 06970564410567 | K052013 | 000 |
| 06970564410895 | K052013 | 000 |
| 06970564410888 | K052013 | 000 |
| 06970564410871 | K052013 | 000 |
| 06970564410864 | K052013 | 000 |
| 06970564410840 | K052013 | 000 |
| 06970564410833 | K052013 | 000 |
| 06970564410819 | K052013 | 000 |
| 06970564410802 | K052013 | 000 |
| 06970564410796 | K052013 | 000 |
| 06970564410772 | K052013 | 000 |
| 06970564410703 | K052013 | 000 |
| 06970564410598 | K052013 | 000 |
| 06970564410581 | K052013 | 000 |
| 06970564410109 | K052013 | 000 |