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FDA 510(k)

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

K-Number: K253217 · 2025-12-23

ApplicantMedimaging Integrated Solution, Inc (Miis)
Decision Date2025-12-23
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253217. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)?

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K253217.

When did MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) receive FDA 510(k) clearance?

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253217.

Who is the listed applicant for MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)?

The FDA 510(k) record lists Medimaging Integrated Solution, Inc (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)?

The FDA product code for MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) is HRX.

Other records listing Medimaging Integrated Solution, Inc (Miis) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video BoxK223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxK214050ENT Nasopharyngoscope and AccessoriesK193188MiiS Horus Eye Anterior CameraK181260MiiS Horus Scope DPT 100K170470Digital Eye Anterior Camera

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLCK252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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