Identity
- Trade Name
- VERITON CT FDA UDI
- Generic Name
- SPECT/CT system FDA UDI
- Device Name
- Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging. FDA UDI
- Model / Reference
- VERITON CT 416 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
- 8010421-01 FDA UDI
- Primary DI / UDI-DI
- 07290108670172 FDA UDI
- 510(k) Number
- K230600 FDA UDI
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- GMDN Term
- SPECT/CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: SPECT/CT system
Veriton Ct by Spectrum Dynamics Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spectrum Dynamics Medical Inc.
Sources (1)
- FDA UDI 6fb2cdb9-9ddb-49c7-87d2-26f971c8ec75 35 fields · synced May 31, 2026