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)

MEDSYNAPSE Zero Footprint Viewer

K-Number: K163158 · 2016-12-02

ApplicantMedsynaptic Private, Ltd.
Decision Date2016-12-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDSYNAPSE Zero Footprint Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Medsynaptic Private, Ltd.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K163158. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDSYNAPSE Zero Footprint Viewer?

MEDSYNAPSE Zero Footprint Viewer is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Medsynaptic Private, Ltd.. The 510(k) number is K163158.

When did MEDSYNAPSE Zero Footprint Viewer receive FDA 510(k) clearance?

MEDSYNAPSE Zero Footprint Viewer received FDA 510(k) clearance on 2016-12-02, under 510(k) number K163158.

Who is the listed applicant for MEDSYNAPSE Zero Footprint Viewer?

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

What is the FDA product code for MEDSYNAPSE Zero Footprint Viewer?

The FDA product code for MEDSYNAPSE Zero Footprint Viewer is LLZ.

Other records listing Medsynaptic Private, 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.

K192508Medsynapse Ris Pacs & Medsynapse VNA

Related Devices (Code: LLZ)

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.

K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.K260500ResolutionMDResolutionMD, Inc.K262120Avara ViewerAvara Software

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.

↑