Identity
- Trade Name
- Delta4 Phantom+ MR FDA UDI
- Generic Name
- Multi-modality therapeutic radiation phantom, anthropomorphic FDA UDI
- Device Name
- The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking). • quality assurance of the radiation delivery system. FDA UDI
- Model / Reference
- PW FDA UDI
- Description
- The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking). • quality assurance of the radiation delivery system. FDA UDI
Identifiers
- Catalog Number
- SDOS101-34 FDA UDI
- Primary DI / UDI-DI
- 17350005180086 FDA UDI
- 510(k) Number
- K183606 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Multi-modality therapeutic radiation phantom, anthropomorphic 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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Multi-modality therapeutic radiation phantom, anthropomorphic
Delta4 Phantom+ MR by Scandidos AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- EASY SLAB — L A P GMBH LASER APPLIKATIONEN · Class I
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- EASY CUBE — L A P GMBH LASER APPLIKATIONEN · Class I
Cleared under the same submission
K183606 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
- Scandidos AB
Sources (1)
- FDA UDI 3aea9646-c7ec-46d2-a860-d4f2d300cf7c 36 fields · synced May 29, 2026