Identity
- Trade Name
- SpotLight Duo FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- SpotLight Duo is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system. FDA UDI
- Model / Reference
- SpotLight FDA UDI
- Description
- SpotLight Duo is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016484021 FDA UDI
- 510(k) Number
- K213465 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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: Full-body CT system
SpotLight Duo by Arineta , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Full-body CT system.
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- syngo. CT Pulmo 3D — Siemens Healthcare · Class II
Cleared under the same submission
K213465 also covers:
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
- Arineta , Ltd.
Sources (1)
- FDA UDI ce2763a2-7812-4c1a-bb74-8bf6ca228bcd 35 fields · synced Jun 6, 2026