FDA 510(k)

IQ-UIP

K-Number: K242467 · 2024-12-19

Decision Date2024-12-19

Product CodeQWO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IQ-UIP is the device name listed in this FDA 510(k) record. The listed applicant is Imbio, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242467. The device is classified under product code QWO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQ-UIP?

IQ-UIP is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Imbio, Inc.. The 510(k) number is K242467.

When did IQ-UIP receive FDA 510(k) clearance?

IQ-UIP received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242467.

Who is the listed applicant for IQ-UIP?

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 IQ-UIP?

The FDA product code for IQ-UIP is QWO.

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.

K241847Imbio PHA (4.0.0)K230112CAC Software K203256Imbio RV/LV Software K180129Imbio Segmentation Editing Tool software

Related Devices (Code: QWO)

K252041Fibresolve (with PCCP)Imvaria, Inc.K241891ScreenDxImvaria, Inc.

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.