Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MiiS Horus Scope DPT 100

K-Number: K181260 · 2019-06-21

ApplicantMedimaging Integrated Solution, Inc (Miis)
Decision Date2019-06-21
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MiiS Horus Scope DPT 100 is a medical device manufactured by Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2019-06-21 under approval number K181260. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiiS Horus Scope DPT 100?

MiiS Horus Scope DPT 100 is a medical device that received FDA 510(k) clearance on 2019-06-21. It is manufactured by Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K181260.

When was MiiS Horus Scope DPT 100 approved by the FDA?

MiiS Horus Scope DPT 100 received FDA 510(k) clearance on 2019-06-21, under approval number K181260.

What company makes MiiS Horus Scope DPT 100?

MiiS Horus Scope DPT 100 is manufactured by Medimaging Integrated Solution, Inc (Miis).

What is the FDA product code for MiiS Horus Scope DPT 100?

The FDA product code for MiiS Horus Scope DPT 100 is HKX.

Other Devices by Medimaging Integrated Solution, Inc (Miis)

K170470Digital Eye Anterior Camera K193188MiiS Horus Eye Anterior Camera K214050ENT Nasopharyngoscope and Accessories K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box K234113MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

View all 7 devices →

Related Devices (Code: HKX)

K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation K190382Intraocular Pressure Tonometer EASYTONCompany Elamed K181143Keeler TonoCare TonometerKeeler Instruments, Inc. K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc. K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon Corporation

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.

↑