The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Opti 110/12/50hsg.
| Device ID | K810190 |
| 510k Number | K810190 |
| Device Name: | OPTI 110/12/50HSG |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-23 |
| Decision Date | 1981-03-02 |