Eclipse Treatment Planning System 15.0

by Varian Medical Systems, Inc.

Eclipse Treatment Planning System 15.0 is a Class II device made by Varian Medical Systems, Inc., cleared under FDA 510(k) K152393 on 18 Sep 2015 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00855141006011), active as of 8 Nov 2026. One FDA recall is 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

1 closed

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00855141006011 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK152393	Date18 Sep 2015Issued	StatusActive

Official records

AccessGUDID record UDI-DI 00855141006011
FDA 510(k) database 510(k) number K152393

Across registries

2 registries list this device

FDA 510(k) K152393 decided 18 Sep 2015 Active
FDA GUDID UDI-DI 00855141006011 listed 16 Sep 2016 Listed

Recalls

1 recall · FDA

- Terminated Z-0805-2016 FDA Class II initiated 11 Jan 2016
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.

Timeline

3 dated events

18 Sep 2015 Cleared FDA 510(k) K152393
11 Jan 2016 Recall initiated FDA recalls Z-0805-2016
16 Sep 2016 Listed FDA GUDID 00855141006011

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Eclipse Treatment Planning System
Generic name: Radiation therapy software
Model / reference: 15.0

Primary DI / UDI-DI: 00855141006011
510(k) Number: K152393
FDA product code: MUJ
GMDN term: Radiation therapy software

Device class: Class II
Regulation number: 892.5050
GUDID distribution status: In Commercial Distribution

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Properties

Lot / batch number

Other properties (14, all answered No)