510(k) · Cleared

Cleared

Observer Ultrasound Reporting and Imaging System

K022877510(k) TraditionalCleared Feb 5, 2003159-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

Vision Chips, Inc. · LLZ System, Image Processing, Radiological

Cleared on Feb 5, 2003 as substantially equivalent to K963610 (A.L.I. Technologies, Inc., 1996) and 2 other predicates after a 159-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.

Decided: Feb 5, 2003
Review: 159 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K955092 (1996). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
1 generation backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
This deviceK022877 Observer Ultrasound Reporting and Imaging SystemVision Chips, Inc. · 2003
Descendant · cites it directly · 1 of its ownK051639 AS-Obgyn Information System; as-Emr SystemAs Software, Inc. · 2005 · Recalled
Descendant · 2 generations on · 0 of its ownK260205 AS Software Version AseraAS Software, LLC · 2026

Most influential descendants

Showing 2 of 2 · See all

K051639AS-Obgyn Information System; as-Emr SystemAs Software, Inc. · 2005 · cites it directly1descendant
K260205AS Software Version AseraAS Software, LLC · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K955092	Accurad Image Management System, Autorad, Regustration Station, Archive…	Cemax-Icon, Inc.	1996	—
−1	K963610	Aki Compacs Data Compresion Module for Diagnostic Images	A.L.I. Technologies, Inc.	1996	—
0 (this device)	K022877	Observer Ultrasound Reporting and Imaging System	Vision Chips, Inc.	2003	—
+1	K051639	AS-Obgyn Information System; as-Emr System	As Software, Inc.	2005	1
+2	K260205	AS Software Version Asera	AS Software, LLC	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2026	1	0

FIG. 1 — Lineage of K022877, 1996–2026Source: 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? (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
*	K963610	Aki Compacs Data Compresion Module for Diagnostic Images Summary page 2 …al Equivalence: OBserver Ultrasound Reporting and Imaging System is substantially equivalent to the following legally-marketed devices: 1) ALI Ultras PACS and comPACS (K963610) 2) R4's Remote Fetal Medicine Ultrasound System. (K000443) 3) Digisonics OB-View (K970402) OBserver Ultrasound Reporting & Imagi…	A.L.I. Technologies, Inc.	1996	—
*	K000443	Remote Fetal Medicine Ultrasound System Summary page 2 …System is substantially equivalent to the following legally-marketed devices: 1) ALI Ultras PACS and comPACS (K963610) 2) R4's Remote Fetal Medicine Ultrasound System. (K000443) 3) Digisonics OB-View (K970402) OBserver Ultrasound Reporting & Imaging System, like R4's Remote Fetal Medicine Ultrasound Syste…	R4 Telemedicine, Inc.	2000	—
*	K970402	Doctors Review System Summary page 2 …nt to the following legally-marketed devices: 1) ALI Ultras PACS and comPACS (K963610) 2) R4's Remote Fetal Medicine Ultrasound System. (K000443) 3) Digisonics OB-View (K970402) OBserver Ultrasound Reporting & Imaging System, like R4's Remote Fetal Medicine Ultrasound System, Digisonics' OB-View, and ALI'…	Digisonics, Inc.	1997	5

Also cleared against K963610: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K051639	AS-Obgyn Information System; as-Emr System	As Software, Inc.	2005	1

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 6.2 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K051639 (As Software, Inc., 2005) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K963610.

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?

OBserver Ultrasound Reporting and Imaging System is intended to automate and enhance the process by which ultrasound examination information is entered and reported and by which ultrasound images are stored and reviewed by physicians in the field of maternal-fetal medicine. The system also provides significant research data for academic institutions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022877 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022877: Observer Ultrasound Reporting and Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022877

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