510(k) · Cleared

Cleared

Encompass.Net

K053455510(k) TraditionalCleared Jan 25, 200647-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

Empiric Systems, LLC · LLZ System, Image Processing, Radiological

Cleared on Jan 25, 2006 as substantially equivalent to K022970 (Amicas, Inc., 2002) after a 47-day review. Its family tree reaches back 4 generations to 1996.

Decided: Jan 25, 2006
Review: 47 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K954678 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
1 generation backK022970 Amicas Light Beam Workstation, Model 1.0Amicas, Inc. · 2002
This deviceK053455 Encompass.NetEmpiric Systems, LLC · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K954678	Pro Vision	Algotec Systems, Ltd.	1996	—
−3	K980648	Pro Vision	Algotec Systems, Ltd.	1998	—
−2	K992654	Plug 'N View 3D, Version 1.0	Voxar Limited	1999	—
−1	K022970	Amicas Light Beam Workstation, Model 1.0	Amicas, Inc.	2002	—
0 (this device)	K053455	Encompass.Net	Empiric Systems, LLC	2006	—

FIG. 1 — Lineage of K053455, 1996–2006Source: 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
*	K022970	Amicas Light Beam Workstation, Model 1.0 Summary page 1 …lassification: 892.2050 System, Image Processing Product Code: LLZ Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K022970 Regulation Number 892.2050 Device Name Amnicas Light Beam Workstation Applica…	Amicas, Inc.	2002	—

Also cleared against K022970: 2 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 10 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K022970.

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.

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?

Encompass.NetTM device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.NetTM receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. Lossy compressed mammographic…

Read the full statement (124 words)

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053455: Encompass.Net.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053455

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