AGILITY— 510(k) K121328
Substantially EquivalentElekta , Ltd.
FDA 510(k) clearance K121328 for AGILITY, Substantially Equivalent on 2012-06-12. Applicant: Elekta , Ltd.. Device class: 2.
Clearance details
- Applicant
- Elekta , Ltd.
- 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 , Ltd.
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 K121328
K-number listed on FDA's recall record- Z-1084-2014 — Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
- Z-1402-2013 — Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
- Z-2340-2012 — Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121328.
Data sourced from openFDA. This site is unofficial and independent of the FDA.