Identity
- Trade Name
- Half Gentle Slope FDA UDI
- Generic Name
- X-ray/radiation therapy beam filter, wedge FDA UDI
- Model / Reference
- FI-03A FDA UDI
Identifiers
- Primary DI / UDI-DI
- B525FI03A0 FDA UDI
- 510(k) Number
- K972766 FDA UDI
- FDA Product Code
- KPR FDA UDI
- GMDN Term
- X-ray/radiation therapy beam filter, wedge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray/radiation therapy beam filter, wedge
Half Gentle Slope by Octostop Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray/radiation therapy beam filter, wedge.
- Wedge Assembly, 30 Degrees — Aktina Corp. · Class II
- Wedge Filter, Cross- Plane, Digital, 60 Degrees, Siemens — Aktina Corp. · Class II
- Wedge Filter, In- Plane, MLC, 30 Degrees, Siemens — Aktina Corp. · Class II
- Wedge Filter, Cross- Plane, MLC, 45 Degrees, Siemens — Aktina Corp. · Class II
- Wedge Filter, Cross- Plane, Digital, 15 Degrees, Siemens — Aktina Corp. · Class II
- Wedge Filter, In- Plane, Digital, 60 Degrees, Siemens — Aktina Corp. · Class II
- Wedge Filter, In- Plane, MLC, 45 Degrees, Siemens — Aktina Corp. · Class II
- Wedge Filter, Cross- Plane, MLC, 60 Degrees, Siemens — Aktina Corp. · Class II
Cleared under the same submission
K972766 also covers:
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
- Octostop Inc
Sources (1)
- FDA UDI 02e27a0d-4657-426b-8fa4-39f9d17730d0 33 fields · synced May 30, 2026