Submission Details
| 510(k) Number | K182484 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2018 |
| Decision Date | November 09, 2018 |
| Days to Decision | 59 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Abbreviated
VERITON CT whole body SPECT/CT system
Nov 2018
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K182484 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. (Caesarea, IL). The FDA issued a Cleared decision on November 9, 2018, 59 days after receiving the submission on September 11, 2018. 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
Similar Devices — KPS System, Tomography, Computed, Emission
All 468
K253564 · Shanghai United Imaging Healthcare Co., Ltd.
· Feb 2026
K254001 · Spectrum Dynamics Medical, Ltd.
· Jan 2026
K253844 · Mediso Medical Imaging Systems, Ltd.
· Dec 2025
K251370 · Canon Medical Systems Corporation
· Dec 2025
K251401 · Trustees of the University of Pennsylvania
· Nov 2025
K252477 · Hermes Medical Solutions AB
· Sep 2025
More from Spectrum Dynamics Medical,...
View all
K254001
· KPS · Jan 2026
K253532
· QIH · Dec 2025
K230600
· KPS · Apr 2023
K212230
· LLZ · Aug 2021
K190457
· KPS · Jul 2019