VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more model
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- VERITON CT 316 EUDAMEDVERITON CT FDA UDI
- Generic Name
- SPECT/CT system FDA UDI
- Device Name
- VERITON CT EUDAMEDSingle Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging. FDA UDI
- Model / Reference
- VERITON CT EUDAMED8010419-01 EUDAMEDVERITON CT 316 FDA UDI
- Description
- Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging. FDA UDI
Identifiers
- Catalog Number
- 8010419-01 FDA UDI
- Primary DI / UDI-DI
- 07290108670226 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010867VERITONCT22 EUDAMED
- Direct Marketing DI
- 07290108670226 EUDAMED
- 510(k) Number
- FDA Product Code
- KPS FDA 510(k)FDA UDIJAK FDA UDI
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
- GMDN Term
- SPECT/CT system FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)FDA UDI892.1750 FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Veriton CT 300 and 400 Series are hybrid Digital Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) systems designed for simultaneous functional and anatomical imaging. These devices combine nuclear medicine imaging with CT to provide precise localization and characterization of radiotracer uptake, improving diagnostic accuracy for conditions such as oncology, cardiology, and neurology.
Used in radiology departments, these systems are intended for single-patient use and are not reusable. The Veriton CT 300 and 400 Series feature ring-shaped gantries with 12 digital CZT detectors, enabling 360° total body imaging. They comply with FDA 510(k) and MDR regulatory requirements, with clearance under the Radiology advisory committee. Models include the Veriton CT 316/364 (Series 300) and Veriton CT 416/464 (Series 400).
Manufacturer's product page: VERITON Series
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364 ..., VERITON Series - spectrum-dynamics, VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364 ..., PDF VERITON-CT Series - spectrum-dynamics.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230600 | Class II | Active |
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Manufacturer
- Manufacturer
- Spectrum Dynamics Medical ltd
- FDA Applicant
- Spectrum Dynamics Medical, Ltd.
Sources (3)
- FDA 510(k) K230600 24 fields · synced Sep 18, 2026
- FDA UDI bf68f3b4-a1ac-46ff-bae0-5141d9d83e5e 35 fields · synced May 27, 2026
- EUDAMED 9474ce59-02ae-4e84-945d-360270428abb 61 fields · synced Jul 12, 2026