Home / 510(k) Clearances / K232100

510(k) K232100

Efai Pacs Picture Archiving and Communication System Pro by Ever Fortune.Ai, Co., Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2023
Date Received
July 14, 2023
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 Ever Fortune.Ai, Co., Ltd.

  • K251306 — Seg Pro V3 (RT-300) (January 28, 2026)
  • K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (February 20, 2025)
  • K241923 — EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (December 6, 2024)
  • K234042 — EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (June 7, 2024)
  • K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (April 8, 2024)
  • K231025 — EFAI NeuroSuite CT ICH Assessment System (October 4, 2023)
  • K231928 — EFAI RTSUITE CT HCAP-Segmentation System (September 25, 2023)
  • K221552 — EFAI ChestSuite XR Pneumothorax Assessment System (November 8, 2022)
  • K222076 — EFAI ChestSuite XR Pleural Effusion Assessment System (September 8, 2022)
  • K213731 — EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows (May 31, 2022)

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)