Skip to content

Pinnacle3®

by Philips Medical Systems (Cleveland), Inc. United States EUDAMEDGUDID

Ref 459801630824Model 16.4.3

Product code MUJEMDN Z11010401

Regulatory status

as of 25 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884838102965 Basic UDI-DIDate5 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838102965 UDI-DIDate10 Nov 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2570-2025 FDA Class II initiated 5 Aug 2025

    Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

    • Ongoing Z-2239-2025 FDA Class II initiated 17 Jul 2025

    Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

    • Ongoing Z-1744-2022 FDA Class II initiated 30 Aug 2022

    When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Pinnacle3® EUDAMED
Pinnacle Radiation Therapy Planning System GUDID
Generic Name
Radiation therapy software
Device Name
Pinnacle3® Radiation Therapy Planning System
Model / Ref / Catalog
16.4.3 EUDAMED
459801630824 EUDAMED
16.4 GUDID
45980163082X GUDID
Primary DI / UDI-DI
00884838102965
Basic UDI-DI
B-00884838102965
510(k) Number
FDA Product Code
MUJ
EMDN Code
Z11010401 Radiotherapy treatment planning systems
GMDN Term
Radiation therapy software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.5050
Special Device Type
-1192
Market of Registration
Bulgaria
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
16.4.3
459801630824
GUDID
16.4
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008701
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Other devices from Philips Medical Systems (Cleveland), Inc.

See all devices from Philips Medical Systems (Cleveland), Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 2eb3c7ea-3ee6-4dcf-9c20-a9119971707e 61 fields · synced 22 Oct 2026
  • FDA UDI 8b217f94-a3cb-4b49-915a-a86eb8dec310 36 fields · synced 30 May 2026