Identity
- Trade Name
- Pinnacle Radiation Therapy Planning System FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Model / Reference
- 18.0 FDA UDI
Identifiers
- Catalog Number
- 45980171803X FDA UDI
- Primary DI / UDI-DI
- 00884838103566 FDA UDI
- 510(k) Number
- K170086 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
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
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: Radiation therapy software
Pinnacle Radiation Therapy Planning System by Philips Medical Systems (Cleveland), Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Radiation therapy software.
- RT Elements - Dose Review — Brainlab SE · Class II
- RayStation — RaySearch Laboratories AB (PUBL) · Class II
- Odyssey — Permedics, Inc. · Class II
- Limbus Contour — Limbus Ai Inc. · Class II
- ThinkQA Edition 2 — Dosisoft SA · Class II
- RayStation — RaySearch Laboratories AB (PUBL) · Class II
- Adaptive Hybrid Surgery Analysis — Brainlab SE · Class II
- Varian DoseLab TG-142 — Varian Medical Systems, Inc · Class I
Cleared under the same submission
K170086 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
Sources (1)
- FDA UDI 2e67a5ab-77c8-42df-b029-3c974343bf73 36 fields · synced Jun 9, 2026