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FDA 510(k)

ALADDIN HW3.0

K-Number: K160327 · 2016-10-05

ApplicantVisia Imaging S.R.L.
Decision Date2016-10-05
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALADDIN HW3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Visia Imaging S.R.L.. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K160327. 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 ALADDIN HW3.0?

ALADDIN HW3.0 is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Visia Imaging S.R.L.. The 510(k) number is K160327.

When did ALADDIN HW3.0 receive FDA 510(k) clearance?

ALADDIN HW3.0 received FDA 510(k) clearance on 2016-10-05, under 510(k) number K160327.

Who is the listed applicant for ALADDIN HW3.0?

The FDA 510(k) record lists Visia Imaging S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALADDIN HW3.0?

The FDA product code for ALADDIN HW3.0 is HJO.

Other records listing Visia Imaging S.R.L. 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.

K222933MYAHK211868MYAH

Related Devices (Code: HJO)

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.

K253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.K173771IOLMaster 700Carl Zeiss Meditec, AG

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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