Submission Details
| 510(k) Number | K161740 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 2016 |
| Decision Date | November 04, 2016 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
D-SPECT Scanner, D-SPECT L Scanner
Nov 2016
Decision
133d
Days
Class 2
Risk
About This 510(k) Submission
K161740 is an FDA 510(k) clearance for the D-SPECT Scanner, D-SPECT L Scanner, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Spectrum Dynamics Medical, Ltd. (North Industrial Park. Caesarea, IL). The FDA issued a Cleared decision on November 4, 2016, 133 days after receiving the submission on June 24, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.
Device Classification
| Product Code | KPS — System, Tomography, Computed, Emission |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1200 |
Manufacturer
Spectrum Dynamics Medical, Ltd.
North Industrial Park. Caesarea · IL
Igor Naroditsky
8 submissions
8 cleared
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