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510(k) K253217

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) by Medimaging Integrated Solution, Inc (Miis) — Product Code HRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2025
Date Received
September 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arthroscope
Device Class
Class II
Regulation Number
888.1100
Review Panel
OR
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Medimaging Integrated Solution, Inc (Miis)

  • K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus (May 1, 2024)
  • K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box (October 6, 2023)
  • K214050 — ENT Nasopharyngoscope and Accessories (July 1, 2022)
  • K193188 — MiiS Horus Eye Anterior Camera (January 14, 2020)
  • K181260 — MiiS Horus Scope DPT 100 (June 21, 2019)
  • K170470 — Digital Eye Anterior Camera (October 6, 2017)

Other clearances for product code HRX

  • K252546 — VantageTM Lumbar Decompression Kit (March 12, 2026)
  • K250795 — PUREVUE™ FMS (December 5, 2025)
  • K252666 — Articulator Arthroscopic Bur (November 21, 2025)
  • K252458 — Kyphoplasty Balloon Dilatation Catheters (November 3, 2025)
  • K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
  • K252594 — UltraGuideCTR® image guided soft tissue release system (September 29, 2025)
  • K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
  • K241990 — SpineSite Endoscope System (July 30, 2025)
  • K243602 — Arthrex Spine Endoscope (May 16, 2025)
  • K242417 — VECTR – Video Endoscopic Carpal Tunnel Release System (December 11, 2024)