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Carbon Fiber Center-Spine Insert, Siemens
FDA UDIClass II (US FDA UDI)
by Aktina Corp.
Identity
- Trade Name
- Carbon Fiber Center-Spine Insert, Siemens FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Model / Reference
- 56-291 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365562910 FDA UDI
- 510(k) Number
- K993522 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
Carbon Fiber Center-Spine Insert, Siemens by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiological whole-body positioner.
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Cleared under the same submission
K993522 also covers:
- Carbon Fiber Mesh Table Insert, Central Openings — Aktina Corp.
- Carbon Fiber Solid Insert, Side Opening — Aktina Corp.
- Carbon Fiber Table Insert — Aktina Corp.
- Mesh Insert Side Opening, Short Version — Aktina Corp.
- Mesh Insert, Carbon Fiber, Side Opening, Long Version — Aktina Corp.
- Metal Frame Table Insert, Elekta Precise — Aktina Corp.
- Solid Carbon Fiber Table Insert, Central Opening — Aktina Corp.
- Tennis Racquet Insert, Siemens 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aktina Corp.
Sources (1)
- FDA UDI 00aa1b41-748e-42cc-895e-4f9f5810086d 33 fields · synced Jun 1, 2026