The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Achieva Family.
| Device ID | K043147 |
| 510k Number | K043147 |
| Device Name: | ACHIEVA FAMILY |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Lynn T Harmer |
| Correspondent | Lynn T Harmer PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2005-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970564410758 | K043147 | 000 |
| 06970564410451 | K043147 | 000 |
| 06970564410390 | K043147 | 000 |
| 06970564410338 | K043147 | 000 |