Identity
- Trade Name
- .decimal P.D FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- p.d software aid's radiation therapy professionals in the design, construction, and testing of radiotherapy beam modifying devices. FDA UDI
- Model / Reference
- 5.1 FDA UDI
- Description
- p.d software aid's radiation therapy professionals in the design, construction, and testing of radiotherapy beam modifying devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851147007069 FDA UDI
- 510(k) Number
- K151369 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Radiation therapy software 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
Yes
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: Radiation therapy software
.decimal P.D by .Decimal, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- .Decimal, LLC
Sources (1)
- FDA UDI f53686e9-ce69-4f8f-a215-38e53210d475 35 fields · synced Jun 8, 2026