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Electron Beam Shaping System, Elekta Compatible, Full System
FDA UDIClass II (US FDA UDI)
by Aktina Corp.
Identity
- Trade Name
- Electron Beam Shaping System, Elekta Compatible, Full System FDA UDI
- Generic Name
- Radiation therapy beam block production plate FDA UDI
- Model / Reference
- 11-270 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365112700 FDA UDI
- 510(k) Number
- K973953 FDA UDI
- FDA Product Code
- IXI FDA UDI
- GMDN Term
- Radiation therapy beam block production plate 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: Radiation therapy beam block production plateRadiation therapy beam block production hot-wire
Electron Beam Shaping System, Elekta Compatible, Full System by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy beam block production hot-wire.
- Styro-former, Basic SF319A — HUESTIS MACHINE CORP. · Class I
- Compu-Cutter 111 — HUESTIS MACHINE CORP. · Class II
- Electron Beam Shaping Full System, Siemens 95 cm, Full System — Aktina Corp. · Class II
- Hot Wire Cutter — Aktina Corp. · Class II
Cleared under the same submission
K973953 also covers:
- E-Beam Shaping System — Aktina Corp.
- Electron Beam Shaping Full System, Siemens 95 cm, Full System — Aktina Corp.
- Hot Wire Cutter — Aktina Corp.
- Universal Leveling Plate System, Elekta Compatible — Aktina Corp.
- Universal Leveling Template, 10X10 — Aktina Corp.
- Universal Leveling Template, 10X10 — Aktina Corp.
- Universal Leveling Template, 14X14 — Aktina Corp.
- Universal Leveling Template, 20X20 — Aktina Corp.
- Universal Leveling Template, 25X25 — Aktina Corp.
- Universal Leveling Template, 6X10 — Aktina Corp.
- Universal Leveling Template, 6X6 — Aktina Corp.
- Universal Leveling Template, Set of Five — 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 6a61fe04-8e70-4fa7-b7c1-cafb8dbbe050 33 fields · synced May 30, 2026