Identity
- Trade Name
- Beam Block Set, High Energy FDA UDI
- Generic Name
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized FDA UDI
- Model / Reference
- 53-426 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365534260 FDA UDI
- 510(k) Number
- K974239 FDA UDI
- FDA Product Code
- IXI FDA UDI
- GMDN Term
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5710 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual-aperture-control therapeutic x-ray system collimator, non-motorized
Beam Block Set, High Energy by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual-aperture-control therapeutic x-ray system collimator, non-motorized.
- Beam Block Tray, Lexan, Solid, Set of 50 — Aktina Corp. · Class II
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- Smart Tray, Siemens, Star Hole Pattern, Lexan, Cross-Hairs — Aktina Corp. · Class II
- Beam Block Tray, Lexan, Solid, Set of 10 — Aktina Corp. · Class II
- Mesh Beam Block Tray, Varian Compatible — Aktina Corp. · Class II
- Beam Block Tray, Acrylic, Solid, Set of 10 — Aktina Corp. · Class II
- Beam Block Tray, Lexan, Solid, Siemens Conv 600 — Aktina Corp. · Class II
Cleared under the same submission
K974239 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
- Aktina Corp.
Sources (1)
- FDA UDI 53c5aa42-2a73-4b7a-9a06-0aa8cb7344dd 33 fields · synced Jun 8, 2026