The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Mdixon Software Option For Intera 1.5t, Achieva 1.5t & Achieva 3.0t Mr Systems.
| Device ID | K102344 |
| 510k Number | K102344 |
| Device Name: | MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98041 -8431 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98041 -8431 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-18 |
| Decision Date | 2010-11-09 |
| Summary: | summary |