The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for 3d Apt.
Device ID | K172920 |
510k Number | K172920 |
Device Name: | 3D APT |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684pc |
Contact | Jan Van De Kerkhof |
Correspondent | Susan Quick Philips Medical Systems (Cleveland) Inc. 595 Miner Rd Cleveland, OH 44143 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-25 |
Decision Date | 2018-01-22 |
Summary: | summary |