← Back to catalogue
Circular Small Field Cone Insert, Elekta, 11mm
FDA UDIClass II (US FDA UDI)
by Aktina Corp.
Identity
- Trade Name
- Circular Small Field Cone Insert, Elekta, 11mm FDA UDI
- Generic Name
- Fixed-aperture therapeutic x-ray system collimator FDA UDI
- Model / Reference
- 50-302-110 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365503021100 FDA UDI
- 510(k) Number
- K161984 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Fixed-aperture therapeutic x-ray system collimator 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
No
FDA UDI
Category: Fixed-aperture therapeutic x-ray system collimator
Circular Small Field Cone Insert, Elekta, 11mm by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-aperture therapeutic x-ray system collimator.
- Varian Integrated Collimator Verification and Interlock system (ICVI) — Varian Medical Systems, Inc · Class II
- Integrated Collimator Verification and Interlock System (ICVI) — Varian Medical Systems, Inc · Class II
- Circular Small Field Cone Insert, Varian, 23mm — Aktina Corp. · Class II
- Small Field Cone Adapter, Elekta — Aktina Corp. · Class II
- Circular Small Field Cone Insert, Varian, 11mm — Aktina Corp. · Class II
- Circular Small Field Cone Insert, Elekta, 39mm — Aktina Corp. · Class II
- Circular Small Field Cone Insert, Elekta, 28mm — Aktina Corp. · Class II
- Circular Small Field Cone Insert, Elekta, 25mm — Aktina Corp. · Class II
Cleared under the same submission
K161984 also covers:
- Bar Code Reader Kit — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 10mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 12mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 13mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 15mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 16mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 17mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 18mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 20mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 22mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 23mm — Aktina Corp.
- Circular Small Field Cone Insert, Elekta, 24mm — 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 6c5817de-849a-494c-99eb-1510a182e3dd 33 fields · synced Jun 8, 2026