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FDA 510(k)

VisAble.IO

K-Number: K223639 · 2023-08-28

ApplicantTechsomed
Decision Date2023-08-28
Product CodeQTZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VisAble.IO is the device name listed in this FDA 510(k) record. The listed applicant is Techsomed. It received FDA 510(k) clearance on 2023-08-28 under 510(k) number K223639. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisAble.IO?

VisAble.IO is a medical device that received FDA 510(k) clearance on 2023-08-28. The listed applicant is Techsomed. The 510(k) number is K223639.

When did VisAble.IO receive FDA 510(k) clearance?

VisAble.IO received FDA 510(k) clearance on 2023-08-28, under 510(k) number K223639.

Who is the listed applicant for VisAble.IO?

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

What is the FDA product code for VisAble.IO?

The FDA product code for VisAble.IO is QTZ.

Other records listing Techsomed 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.

K240773VisAble.IO

Related Devices (Code: QTZ)

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.

K253264myAblation Guide (VC10A)Siemens Healthcare GmbHK252947HistoSonics® Planning ToolHistoSonics, Inc.K251931BioTraceIO Vision (V1.7)Techsomed Medical TechnologiesK240796myAblation Guide (VB80A)Siemens Healthcare GmbHK240773VisAble.IOTechsomedK222222Artemis, Artemis TPO, Artemis MXEigen

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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