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FDA 510(k)

Digital Eye Anterior Camera

K-Number: K170470 · 2017-10-06

ApplicantMedimaging Integrated Solution, Inc (Miis)
Decision Date2017-10-06
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Digital Eye Anterior Camera is a medical device manufactured by Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2017-10-06 under approval number K170470. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Eye Anterior Camera?

Digital Eye Anterior Camera is a medical device that received FDA 510(k) clearance on 2017-10-06. It is manufactured by Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K170470.

When was Digital Eye Anterior Camera approved by the FDA?

Digital Eye Anterior Camera received FDA 510(k) clearance on 2017-10-06, under approval number K170470.

What company makes Digital Eye Anterior Camera?

Digital Eye Anterior Camera is manufactured by Medimaging Integrated Solution, Inc (Miis).

What is the FDA product code for Digital Eye Anterior Camera?

The FDA product code for Digital Eye Anterior Camera is HJO.

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Other Devices by Medimaging Integrated Solution, Inc (Miis)

K181260MiiS Horus Scope DPT 100 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)

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Related Devices (Code: HJO)

K161972Slit Lamp SL-D301Topcon Corporation K160327ALADDIN HW3.0Visia Imaging S.R.L. K153545Portable Slit LampShanghai Bolan Optical-Electric Co., Ltd. K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. K152429Slit Lamp MicroscopeShanghai Mediworks Precision Instruments Co. , Ltd. K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T 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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