510(k) · Cleared

Cleared

CloudVue

K203058510(k) TraditionalCleared Oct 29, 202021-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

International Medical Solutions, Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 29, 2020 as substantially equivalent to K172490 (Client Outlook, Inc., 2018) after a 21-day review. Its family tree reaches back 2 generations to 2016.

Decided: Oct 29, 2020
Review: 21 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K161515 (2016). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK161515 eUnityClient Outlook, Inc. · 2016
1 generation backK172490 eUnityClient Outlook, Inc. · 2018
This deviceK203058 CloudVueInternational Medical Solutions, Inc. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K161515	eUnity	Client Outlook, Inc.	2016	—
−1	K172490	eUnity	Client Outlook, Inc.	2018	—
0 (this device)	K203058	CloudVue	International Medical Solutions, Inc.	2020	—

FIG. 1 — Lineage of K203058, 2016–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K172490	eUnity Summary page 4 …Device Trade Name eUnity Manufacturer Client Outlook Inc. 510(k) Number K172490 Page 1 of 5 === Page…	Client Outlook, Inc.	2018	—

Also cleared against K172490: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K172490.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

CloudVue is a software application that displays medical image data to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. CloudVue allows users to perform image manipulations, including window/level, rotation, measurement and markup. CloudVue provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images.…

Read the full statement (139 words)

CloudVue allows users to perform image manipulations, including window/level, rotation, measurement and markup.

CloudVue provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images.

CloudVue displays both lossless and lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage only when a full workstation is not available.

Usage for mammography is for reference and referral only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K203058 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203058: CloudVue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203058

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026