510(k) · Cleared

Cleared

Remoteimage System

K994228510(k) TraditionalCleared Feb 22, 200069-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

Etrauma.Com Corp. · LLZ System, Image Processing, Radiological

Cleared on Feb 22, 2000 as substantially equivalent to K970064 (Autocyt Group, Inc., 1997) after a 69-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.

Decided: Feb 22, 2000
Review: 69 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K924178 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
1 generation backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
This deviceK994228 Remoteimage SystemEtrauma.Com Corp. · 2000
Descendant · cites it directly · 0 of its ownK024159 Strykerware SystemStryker Endoscopy · 2003

Most influential descendants

Showing 1 of 1 · See all

K024159Strykerware SystemStryker Endoscopy · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K924178	Medvision (TM) Imaging Software	Evergreen Technologies, Inc.	1993	—
−1	K970064	Amicas Web/Intranet Image Server	Autocyt Group, Inc.	1997	—
0 (this device)	K994228	Remoteimage System	Etrauma.Com Corp.	2000	—
+1	K024159	Strykerware System	Stryker Endoscopy	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K994228, 1993–2003Source: 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? (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
*	K970064	Amicas Web/Intranet Image Server Our OCR of the scanned summary read K870064, FDA’s number for Mobil-Air (Roman Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AMICAS Web/Intranet Image Server”.	Autocyt Group, Inc.	1997	—
†	K933632	Medscan 12	Vidar Systems Corp.	1993	—

Also cleared against K970064: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K024159	Strykerware System	Stryker Endoscopy	2003	0

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 7 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K024159 (Stryker Endoscopy, 2003) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K970064.

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?

The Remotelmage™ System is indicated to be used for remote viewing of medical image data.

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/K994228 · printed Nov 5, 2026

Cite this page

510(k) Report. “K994228: Remoteimage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994228

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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