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Wedge Filter, In- Plane, MLC, 45 Degrees, Siemens
FDA UDIClass II (US FDA UDI)
by Aktina Corp.
Identity
- Trade Name
- Wedge Filter, In- Plane, MLC, 45 Degrees, Siemens FDA UDI
- Generic Name
- X-ray/radiation therapy beam filter, wedge FDA UDI
- Model / Reference
- 56-300-MI45 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B36556300MI450 FDA UDI
- 510(k) Number
- K014081 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- X-ray/radiation therapy beam filter, wedge 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray/radiation therapy beam filter, wedge
Wedge Filter, In- Plane, MLC, 45 Degrees, Siemens by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray/radiation therapy beam filter, wedge.
- Half Gentle Slope — Octostop Inc · Class II
- Boomerang no Chain — Octostop Inc · Class II
- Prism — Octostop Inc · Class II
- Boomerang 15 Degre — Octostop Inc · Class II
- Boomerang — Octostop Inc · Class II
- Gentle Slope — Octostop Inc · Class II
- FI-Kit — Octostop Inc · Class II
- Main Inter-Leg Filter — Octostop Inc · Class II
Cleared under the same submission
K014081 also covers:
- Wedge Assembly, 15 Degrees — Aktina Corp.
- Wedge Assembly, 30 Degrees — Aktina Corp.
- Wedge Assembly, 45 Degrees — Aktina Corp.
- Wedge Assembly, 60 Degrees — Aktina Corp.
- Wedge Filter, Cross- Plane, Digital, 15 Degrees, Siemens — Aktina Corp.
- Wedge Filter, Cross- Plane, Digital, 30 Degrees, Siemens — Aktina Corp.
- Wedge Filter, Cross- Plane, Digital, 45 Degrees, Siemens — Aktina Corp.
- Wedge Filter, Cross- Plane, Digital, 60 Degrees, Siemens — Aktina Corp.
- Wedge Filter, Cross- Plane, MLC, 15 Degrees, Siemens — Aktina Corp.
- Wedge Filter, Cross- Plane, MLC, 30 Degrees, Siemens — Aktina Corp.
- Wedge Filter, Cross- Plane, MLC, 45 Degrees, Siemens — Aktina Corp.
- Wedge Filter, Cross- Plane, MLC, 60 Degrees, Siemens — 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 333f722b-be0e-4f18-af44-787e68ab44fc 33 fields · synced May 30, 2026