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FDA 510(k)

Imbio RV/LV Software

K-Number: K203256 · 2021-03-09

ApplicantImbio, LLC
Decision Date2021-03-09
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Imbio RV/LV Software is the device name listed in this FDA 510(k) record. The listed applicant is Imbio, LLC. It received FDA 510(k) clearance on 2021-03-09 under 510(k) number K203256. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Imbio RV/LV Software?

Imbio RV/LV Software is a medical device that received FDA 510(k) clearance on 2021-03-09. The listed applicant is Imbio, LLC. The 510(k) number is K203256.

When did Imbio RV/LV Software receive FDA 510(k) clearance?

Imbio RV/LV Software received FDA 510(k) clearance on 2021-03-09, under 510(k) number K203256.

Who is the listed applicant for Imbio RV/LV Software?

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

What is the FDA product code for Imbio RV/LV Software?

The FDA product code for Imbio RV/LV Software is QIH.

Other records listing Imbio, LLC 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.

K242467IQ-UIPK241847Imbio PHA (4.0.0)K230112CAC SoftwareK180129Imbio Segmentation Editing Tool software

Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, 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.

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