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Philips 459801630821

by Philips Medical Systems (Cleveland), Inc.

Philips 459801630821 is a Class II device made by Philips Medical Systems (Cleveland), Inc., cleared under FDA 510(k) K170086 on 9 Feb 2017 and listed in FDA GUDID since 27 Feb 2020 (UDI-DI 00884838098992), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K170086

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838098992 UDI-DI Date27 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK170086 Date9 Feb 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170086 decided 9 Feb 2017 Active
  • FDA GUDID UDI-DI 00884838098992 listed 27 Feb 2020 Listed

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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K170086
  2. Listed FDA GUDID 00884838098992
  3. Recall initiated FDA recalls Z-1744-2022
  4. Recall initiated FDA recalls Z-2239-2025
  5. Recall initiated FDA recalls Z-2570-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Philips
Generic name
Radiation therapy software
Model / Ref / Catalog
459801630821
Primary DI / UDI-DI
00884838098992
510(k) Number
FDA product code
MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Cleared under the same submission (K170086)

Similar devices in this category

Other devices filed under Radiation therapy software.

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

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

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)