The following data is part of a premarket notification filed by Syntex Corp. with the FDA for Hi-sensitivity Mode Option For S60-1a.
| Device ID | K761332 |
| 510k Number | K761332 |
| Device Name: | HI-SENSITIVITY MODE OPTION FOR S60-1A |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SYNTEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-27 |
| Decision Date | 1976-12-30 |