The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Radiation Treatment Planning System.
Device ID | K780157 |
510k Number | K780157 |
Device Name: | RADIATION TREATMENT PLANNING SYSTEM |
Classification | System, Therapeutic, X-ray |
Applicant | CAPINTEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-30 |
Decision Date | 1978-02-13 |