The following data is part of a premarket notification filed by S & S Inficon, Inc. with the FDA for Theraview Digital Portal Imaging Computer.
Device ID | K902339 |
510k Number | K902339 |
Device Name: | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER |
Classification | Accelerator, Linear, Medical |
Applicant | S & S INFICON, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
Contact | C Greenway |
Correspondent | C Greenway S & S INFICON, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-24 |
Decision Date | 1990-08-23 |