The following data is part of a premarket notification filed by Scott Imaging Intl., Inc. with the FDA for Sii 360 Apr.
| Device ID | K950041 |
| 510k Number | K950041 |
| Device Name: | SII 360 APR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | SCOTT IMAGING INTL., INC. 3510 COTTAGE HILL RD. Mobile, AL 36609 |
| Contact | Michael W Scott |
| Correspondent | Michael W Scott SCOTT IMAGING INTL., INC. 3510 COTTAGE HILL RD. Mobile, AL 36609 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-05 |
| Decision Date | 1995-03-21 |