The following data is part of a premarket notification filed by Northwest Medical Physics Equipment, Inc. with the FDA for P Reference Tps (treatment Planning Software) 1.1.
Device ID | K970464 |
510k Number | K970464 |
Device Name: | P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 |
Classification | Accelerator, Linear, Medical |
Applicant | NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. ROENTGEN HALL 21031 67TH AVE. W. Lynnwood, WA 98036 |
Contact | Lee Myers |
Correspondent | Lee Myers NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. ROENTGEN HALL 21031 67TH AVE. W. Lynnwood, WA 98036 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-07 |
Decision Date | 1997-09-05 |