Identity
- Trade Name
- isoPoint Validation Software FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test. FDA UDI
- Model / Reference
- 80-800 FDA UDI
- Description
- Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B3658080000 FDA UDI
- FDA Product Code
- LHO FDA UDI
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1940 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Accelerator system quality assurance device
isoPoint Validation Software by Aktina Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Accelerator system quality assurance device.
- Qumulate — Varian Medical Systems, Inc · Class I
- Blue Phantom² — IBA Dosimetry GmbH · Class II
- Standard Imaging QA StereoChecker — STANDARD IMAGING, INC. · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- Standard Imaging TomoScanner — STANDARD IMAGING, INC. · Class I
- StereoPHAN — Sun Nuclear Corporation · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aktina Corp.
Sources (1)
- FDA UDI fa76726e-261d-4e22-a4b8-8a84eddee62d 33 fields · synced Jun 1, 2026