Gating Reflector Block— 510(k) K242874

Substantially Equivalent

Varian Medical Systems, Inc.

FDA 510(k) clearance K242874 for Gating Reflector Block, Substantially Equivalent on 2024-11-21. Applicant: Varian Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant
Varian Medical Systems, Inc.
Product code
Code JAK
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palo Alto, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JAK

product code JAK
Death
27
Injury
571
Malfunction
779
Total
1,377

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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