← Back to catalogue
AK-550 & Elekta Precise Interface Kit
FDA UDIClass II (US FDA UDI)
by Aktina Corp.
Identity
- Trade Name
- AK-550 & Elekta Precise Interface Kit FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Model / Reference
- 51-201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365512010 FDA UDI
- 510(k) Number
- K032248 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Indexed-immobilization patient positioning system 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
Yes
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: Indexed-immobilization patient positioning system
AK-550 & Elekta Precise Interface Kit by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indexed-immobilization patient positioning system.
- QUANTUM™ CT Overlay — Qfix · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- DSPS® Cradle-S H MR — MACROMEDICS B.V. · Class II
- FlexBoard™ BTM-SX — MACROMEDICS B.V. · Class II
- IPPS™ Overlay — Medtec LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
Cleared under the same submission
K032248 also covers:
- 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.
- CT Overlay - Toshiba Compatible — 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 1590fc3b-0635-4fd2-8237-f7dfe1906bc5 33 fields · synced May 30, 2026