510(k) · Cleared

Cleared

Clearviewhd

K140139510(k) TraditionalCleared May 28, 2014126-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

Clearview Diagnostics, Inc. · LLZ System, Image Processing, Radiological

Cleared on May 28, 2014 as substantially equivalent to K993802 (Context Vision AB, 2000) and 2 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1992.

Decided: May 28, 2014
Review: 126 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K922470 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
3 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
2 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
1 generation backK063391 Sapheneia ClaritySapheneia Commercial Products AB · 2007
This deviceK140139 ClearviewhdClearview Diagnostics, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K922470	Ies, Image Enhancement System	Open Mri, Inc.	1992	—
−3	K993802	Sharpview Image Enhancement System	Context Vision AB	2000	—
−2	K024028	Sharp View Image Enhancement System	Context Vision AB	2003	—
−1	K063391	Sapheneia Clarity	Sapheneia Commercial Products AB	2007	—
0 (this device)	K140139	Clearviewhd	Clearview Diagnostics, Inc.	2014	—

FIG. 1 — Lineage of K140139, 1992–2014Source: 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

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What was it cleared against? (3)

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
*	K993802	Sharpview Image Enhancement System Summary page 1 …y and performance, this software medical device is substantially equivalent to the devices listed below: Model: SharpView Manufacturer: ContextVision AB 5 10(k) Number: K993802, K024028 Model: Sapheneia Clarity Manufacturer: Sapheneia Commercial Products AB 5 10(k) Numbers: K063391 510(k) Summary…	Context Vision AB	2000	—
*	K024028	Sharp View Image Enhancement System Summary page 1 …formance, this software medical device is substantially equivalent to the devices listed below: Model: SharpView Manufacturer: ContextVision AB 5 10(k) Number: K993802, K024028 Model: Sapheneia Clarity Manufacturer: Sapheneia Commercial Products AB 5 10(k) Numbers: K063391 510(k) Summary…	Context Vision AB	2003	—
*	K063391	Sapheneia Clarity Summary page 1 …odel: SharpView Manufacturer: ContextVision AB 5 10(k) Number: K993802, K024028 Model: Sapheneia Clarity Manufacturer: Sapheneia Commercial Products AB 5 10(k) Numbers: K063391 510(k) Summary ClearView Diagnostics, Inc. 5-1 4. Device D…	Sapheneia Commercial Products AB	2007	—

Also cleared against K993802: 4 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 22 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
None of the 4 ancestors has a recall.
4 other devices also cite its predicate K993802.

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. 2014, 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?

The ClearView Image Enhancement System is intended for use by a qualified technician or diagnostician to reduce speckle noise, enhance contrast, and transfer ultrasound images. The software provides a DICOM-compliant ClearViewHD-enhanced image along with the original ultrasound image to assist in image interpretation by the trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140139 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140139: Clearviewhd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140139

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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