DeviceClearance

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD— 510(k) K210500

Substantially Equivalent

Elekta Limited

FDA 510(k) clearance K210500 for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, Substantially Equivalent on 2021-06-11. Applicant: Elekta Limited. Device class: 2.

Clearance details

Applicant
Elekta Limited
Product code
Code IYE
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Crawley, GB
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IYE

product code IYE
Malfunction
455
Other
3
Total
458

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 →

Recalls naming K210500

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 K210500.

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