The following data is part of a premarket notification filed by Oncology Systems, Inc. with the FDA for Plan-32 Software.
Device ID | K871810 |
510k Number | K871810 |
Device Name: | PLAN-32 SOFTWARE |
Classification | System, Therapeutic, X-ray |
Applicant | ONCOLOGY SYSTEMS, INC. 10777 MAIN ST. STE.20 Bellevue, WA 98004 |
Contact | Anthony C Naughtin |
Correspondent | Anthony C Naughtin ONCOLOGY SYSTEMS, INC. 10777 MAIN ST. STE.20 Bellevue, WA 98004 |
Product Code | JAD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-08 |
Decision Date | 1987-10-30 |