Company · US

Cleerly, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (3 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
LLZ	System, Image Processing, Radiological	3
QIH	Automated Radiological Image Processing Software	2
QXZ	Adjunctive Epicardial Vascular Physiologic Status Indicator	2

Decided	510(k)	Device and applicant	Code
Oct 29, 2026	K262839	Cleerly ISCHEMIA Cleerly, Inc.	QXZ
Jul 29, 2026	K261210	Cleerly Plaque Cleerly, Inc.	QIH
Jul 29, 2026	K260588	Cleerly LABS Cleerly, Inc.	LLZ
Mar 7, 2025	K242338	Cleerly LABS (v2.0) Cleerly, Inc.	QIH
Sep 8, 2023	K231335	Cleerly ISCHEMIA Cleerly, Inc.	QXZ
Oct 2, 2020	K202280	Cleerly Labs v2.0 Cleerly, Inc.	LLZ
Nov 5, 2019	K190868	Cleerly Labs Cleerly, Inc.	LLZ

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