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)

SmartView 3D Option

K-Number: K153429 · 2016-03-09

ApplicantGe Hangwei Medical System Co., Ltd.
Decision Date2016-03-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SmartView 3D Option is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical System Co., Ltd.. It received FDA 510(k) clearance on 2016-03-09 under 510(k) number K153429. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartView 3D Option?

SmartView 3D Option is a medical device that received FDA 510(k) clearance on 2016-03-09. The listed applicant is Ge Hangwei Medical System Co., Ltd.. The 510(k) number is K153429.

When did SmartView 3D Option receive FDA 510(k) clearance?

SmartView 3D Option received FDA 510(k) clearance on 2016-03-09, under 510(k) number K153429.

Who is the listed applicant for SmartView 3D Option?

The FDA 510(k) record lists Ge Hangwei Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartView 3D Option?

The FDA product code for SmartView 3D Option is JAK.

Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , 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.

↑