FDA 510(k)

Imbio PHA (4.0.0)

K-Number: K241847 · 2024-08-30

Decision Date2024-08-30

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Imbio PHA (4.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Imbio, Inc.. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241847. 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 PHA (4.0.0)?

Imbio PHA (4.0.0) is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Imbio, Inc.. The 510(k) number is K241847.

When did Imbio PHA (4.0.0) receive FDA 510(k) clearance?

Imbio PHA (4.0.0) received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241847.

Who is the listed applicant for Imbio PHA (4.0.0)?

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

What is the FDA product code for Imbio PHA (4.0.0)?

The FDA product code for Imbio PHA (4.0.0) is QIH.

Other records listing Imbio, Inc. 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-UIP K230112CAC Software K203256Imbio RV/LV Software K180129Imbio Segmentation Editing Tool software

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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.