Submission Details
| 510(k) Number | K945708 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 1994 |
| Decision Date | December 14, 1994 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
Cleared
Traditional
SII 360 MS
Dec 1994
Decision
23d
Days
Class 2
Risk
About This 510(k) Submission
K945708 is an FDA 510(k) clearance for the SII 360 MS, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Scott Imaging Intl., Inc. (Mobile, US). The FDA issued a Cleared decision on December 14, 1994, 23 days after receiving the submission on November 21, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
Device Classification
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |
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