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Head and Neck Overlay with Shoulder Restraints
FDA UDIClass II (US FDA UDI)
by Aktina Corp.
Identity
- Trade Name
- Head and Neck Overlay with Shoulder Restraints FDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Model / Reference
- 11-220 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365112200 FDA UDI
- 510(k) Number
- K032248 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Patient positioner base plate 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: Patient positioner base plate
Head and Neck Overlay with Shoulder Restraints by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient positioner base plate.
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- Alta — Qfix · Class II
- MR Posi-S™ Adapter — Medtec LLC · Class II
- Uni-frame® Baseplate — Medtec LLC · Class II
- Prone Head Holder — Medtec LLC · Class I
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 - GE LightSpeed — 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.
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 0a5de4c5-6e14-417a-ad8b-893f5834b1fd 33 fields · synced May 30, 2026