Elekta Unity— 510(k) K192482
Substantially EquivalentElekta Limited
FDA 510(k) clearance K192482 for Elekta Unity, Substantially Equivalent on 2019-12-05. 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
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 K192482
K-number listed on FDA's recall record- Z-2297-2020 — Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
- Z-2289-2020 — Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
- Z-2473-2020 — Elekta Unity, Image-Guided Radiation Therapy System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192482.
Data sourced from openFDA. This site is unofficial and independent of the FDA.