The following data is part of a premarket notification filed by Scott Imaging Intl., Inc. with the FDA for Mts-007, Sts-008, Ssmts-010, Euro-40, 72, Super Euro 4072, 5000.
| Device ID | K946261 |
| 510k Number | K946261 |
| Device Name: | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 |
| Classification | Tube Mount, 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 | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-02-15 |