The following data is part of a premarket notification filed by Northwest Medical Physics Equipment, Inc. with the FDA for Prefernce Imrt Treatment Planning Module.
Device ID | K012575 |
510k Number | K012575 |
Device Name: | PREFERNCE IMRT TREATMENT PLANNING MODULE |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. 21031 67TH AVE. WEST Lynnwood, WA 98036 |
Contact | Lee Myers |
Correspondent | Lee Myers NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. 21031 67TH AVE. WEST Lynnwood, WA 98036 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-09 |
Decision Date | 2002-03-12 |