INTEGRITY(TM)— 510(k) K112613
Substantially EquivalentElekta Limited
FDA 510(k) clearance K112613 for INTEGRITY(TM), Substantially Equivalent on 2011-12-16. 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, West Sussex, GB
Recent devices under product code IYE
view allMore clearances from Elekta Limited
view allAdverse 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 K112613
K-number listed on FDA's recall record- Z-0724-2018 — Integrity R1.2
- Z-1083-2014 — Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
- Z-1322-2014 — Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112613.
Data sourced from openFDA. This site is unofficial and independent of the FDA.