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

FDA 510(k)

Aquarius 8600

K-Number: K170202 · 2017-02-22

ApplicantImaging Dynamics Company , Ltd.
Decision Date2017-02-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquarius 8600 is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company , Ltd.. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K170202. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquarius 8600?

Aquarius 8600 is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Imaging Dynamics Company , Ltd.. The 510(k) number is K170202.

When did Aquarius 8600 receive FDA 510(k) clearance?

Aquarius 8600 received FDA 510(k) clearance on 2017-02-22, under 510(k) number K170202.

Who is the listed applicant for Aquarius 8600?

The FDA 510(k) record lists Imaging Dynamics Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquarius 8600?

The FDA product code for Aquarius 8600 is MQB.

Other records listing Imaging Dynamics Company , Ltd. 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.

K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCIK171169Aquarius 8600 1417TG and Aquarius 8600 1717TGK171175Aquarius 8600 1417WC

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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.

↑