APEX— 510(k) K111676

Substantially Equivalent

Elekta Limited

FDA 510(k) clearance K111676 for APEX, Substantially Equivalent on 2011-09-30. Applicant: Elekta Limited. Device class: 2.

Clearance details

Applicant: Elekta Limited
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2011-06-15
Decision date: 2011-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sussex, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code IXI

K253025 — Ricoh 3D for Healthcare Bolus2026-04-06
K222639 — VHA Radiotherapy Bolus2022-11-04
K214093 — VSP Bolus2022-03-30
K132236 — .DECIMAL PROTON APERTURE2013-10-16
K131150 — CURA COMPENSATOR2013-07-30

More clearances from Elekta Limited

K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD2021-06-11
K192482 — Elekta Unity2019-12-05
K192242 — Synergy Platform, Synergy, Infinity, VersaHD2019-11-22
K182076 — Elekta Unity2018-12-04
K153011 — iViewDose R1.02015-12-11

Recalls naming K111676

K-number listed on FDA's recall record

Z-0885-2013 — Elekta, Apex add-on Micro MLC, collimator for radiation therapy.Class II·Terminated·Elekta, Inc.·20130118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111676.

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