Home / 510(k) Clearances / K252476

510(k) K252476

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout by Brainlab AG — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2025
Date Received
August 7, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Brainlab AG

  • K252562 — Spine & Trauma Navigation Instruments (September 12, 2025)
  • K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (July 22, 2025)
  • K243142 — Cranial 4Pi Immobilization (June 23, 2025)
  • K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (June 17, 2025)
  • K243633 — Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements (June 13, 2025)
  • K243810 — TraumaCad Neo (1.1) (June 4, 2025)
  • K242569 — Mixed Reality Spine Navigation (May 16, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface (July 24, 2024)
  • K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation (May 23, 2024)

Other clearances for product code LLZ

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)