Company · US

Imbio, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2024. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
JAK	System, X-Ray, Tomography, Computed	2
QIH	Automated Radiological Image Processing Software	2
LLZ	System, Image Processing, Radiological	1
QWO	Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.	1

Decided	510(k)	Device and applicant	Code
Dec 19, 2024	K242467	IQ-UIP Imbio, Inc.	QWO
Aug 30, 2024	K241847	Imbio PHA (4.0.0) Imbio, Inc.	QIH
Jun 13, 2023	K230112	CAC Software Imbio, Inc.	JAK
Mar 9, 2021	K203256	Imbio RV/LV Software Imbio, LLC	QIH
Mar 16, 2018	K180129	Imbio Segmentation Editing Tool software Imbio, LLC	LLZ
Sep 17, 2014	K141069	Lung Density Analysis Imbio, LLC	JAK

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.