Submission Details
| 510(k) Number | K190457 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 25, 2019 |
| Decision Date | July 12, 2019 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
VERITON CT whole body SPECT/CT system
Jul 2019
Decision
137d
Days
Class 2
Risk
About This 510(k) Submission
K190457 is an FDA 510(k) clearance for the VERITON CT whole body SPECT/CT system, 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 July 12, 2019, 137 days after receiving the submission on February 25, 2019. 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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