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FDA 510(k)

Medsynapse Ris Pacs & Medsynapse VNA

K-Number: K192508 · 2019-11-22

ApplicantMedsynaptic Private, Ltd.
Decision Date2019-11-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medsynapse Ris Pacs & Medsynapse VNA 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 2019-11-22 under 510(k) number K192508. 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 Ris Pacs & Medsynapse VNA?

Medsynapse Ris Pacs & Medsynapse VNA is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Medsynaptic Private, Ltd.. The 510(k) number is K192508.

When did Medsynapse Ris Pacs & Medsynapse VNA receive FDA 510(k) clearance?

Medsynapse Ris Pacs & Medsynapse VNA received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192508.

Who is the listed applicant for Medsynapse Ris Pacs & Medsynapse VNA?

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 Ris Pacs & Medsynapse VNA?

The FDA product code for Medsynapse Ris Pacs & Medsynapse VNA 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.

K163158MEDSYNAPSE Zero Footprint Viewer

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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