DeviceClearance

Eclipse Treatment Planning System— 510(k) K152393

Substantially Equivalent

Varian Medical Systems, Inc.

FDA 510(k) clearance K152393 for Eclipse Treatment Planning System, Substantially Equivalent on 2015-09-18. Applicant: Varian Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant
Varian Medical Systems, Inc.
Product code
Code MUJ
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Palo Alto, CA, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K152393

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152393.

Data sourced from openFDA. This site is unofficial and independent of the FDA.