The following data is part of a premarket notification filed by S & S Inficon, Inc. with the FDA for Theraview Digital Portal Imaging Computer (mod.).
| Device ID | K920455 |
| 510k Number | K920455 |
| Device Name: | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.) |
| Classification | Accelerator, Linear, Medical |
| Applicant | S & S INFICON, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Timothy A Derrigan |
| Correspondent | Timothy A Derrigan 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 | 1992-01-16 |
| Decision Date | 1992-03-31 |