Identity
- Trade Name
- CT Overlay - GE LightSpeed FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Model / Reference
- 11-467 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365114670 FDA UDI
- 510(k) Number
- K032248 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
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: Radiological whole-body positioner
CT Overlay - GE LightSpeed by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K032248 also covers:
- AK-550 & Elekta Precise Interface Kit — Aktina Corp.
- AK550 Carbon Fiber Table Top, Elekta Precise — Aktina Corp.
- Belly Compression Arch Kit — Aktina Corp.
- Bridge Bar — Aktina Corp.
- C-Arm Solid Panel Insert — Aktina Corp.
- CT Overlay - GE CTi — Aktina Corp.
- CT Overlay - GE LXi — Aktina Corp.
- CT Overlay - Philips AcQsim — Aktina Corp.
- CT Overlay - Philips Brilliance — Aktina Corp.
- CT Overlay - Siemens Compatible — Aktina Corp.
- CT Overlay - Siemens Plus4 / Sensation — Aktina Corp.
- CT Overlay - Toshiba Compatible — Aktina Corp.
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
- Aktina Corp.
Sources (1)
- FDA UDI 89f0f0d5-8d65-45b1-b2aa-c753f193ae92 33 fields · synced Jun 8, 2026