ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5— 510(k) K051932
Substantially EquivalentElekta, Inc.
FDA 510(k) clearance K051932 for ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5, Substantially Equivalent on 2005-08-12. Applicant: Elekta, Inc.. Device class: 2.
Clearance details
- Applicant
- Elekta, Inc.
- 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
- Special
- Location
- Norcross, GA, US
Recent devices under product code IYE
view allMore clearances from Elekta, Inc.
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 K051932
K-number listed on FDA's recall record- Z-2840-2018 — ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
- Z-2721-2016 — Medical Linear Accelerator
- Z-1088-2015 — Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
- Z-1061-2014 — Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
- Z-1065-2014 — All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
- Z-0931-2013 — Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
- Z-2405-2012 — Precise Digital Accelerator 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 K051932.
Data sourced from openFDA. This site is unofficial and independent of the FDA.