510(k) · Cleared

Cleared

Viewstation

K011694510(k) TraditionalCleared Aug 29, 200190-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

Impac Medical Systems, Inc. · LLZ System, Image Processing, Radiological

Cleared on Aug 29, 2001 as substantially equivalent to K942346 (Impac Medical Systems, Inc., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.

Decided: Aug 29, 2001
Review: 90 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K942346 (1995). 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK942346 ImagertImpac Medical Systems, Inc. · 1995
This deviceK011694 ViewstationImpac Medical Systems, Inc. · 2001
Descendant · cites it directly · 9 of its ownK043412 Modification to: ViewstationImpac Medical Systems, Inc. · 2004
Descendant · 2 generations on · 8 of its ownK120067 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
Descendant · 3 generations on · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
Descendant · 4 generations on · 4 of its ownK162468 ClearCheckRadformation · 2016
Descendant · 5 generations on · 3 of its ownK220583 ClearCheck Model RADCC V2Radformation, Inc. · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004high 2 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all

K043412Modification to: ViewstationImpac Medical Systems, Inc. · 2004 · cites it directly9descendants
K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · 2 generations on8descendants
K142142Quality ReportsSun Nuclear Corporation · 2014 · 3 generations on5descendants
K162468ClearCheckRadformation · 2016 · 4 generations on4descendants
K220583ClearCheck Model RADCC V2Radformation, Inc. · 2022 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K942346	Imagert	Impac Medical Systems, Inc.	1995	—
0 (this device)	K011694	Viewstation	Impac Medical Systems, Inc.	2001	—
+1	K043412	Modification to: Viewstation	Impac Medical Systems, Inc.	2004	—
+2	K120067	Mosaiq Oncology Information System	Impac Medical Systems, Inc.	2012	3
+3	K142142	Quality Reports	Sun Nuclear Corporation	2014	—
+4	K162468	ClearCheck	Radformation	2016	—
+5	K220583	ClearCheck Model RADCC V2	Radformation, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2012	2	0
2014	1	0
2016	1	0
2021	1	0
2022	1	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K011694, 1995–2026Source: 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? (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
*	K942346	Imagert Summary page 1 …t the submitter’s Management Representative listed below. Premarket Notification Information 1. Previous Notification Information: a. Previous Premarket Notification K942346 b. Previous Submission Date 12/28/94 c. Product Name IMAGE RT (renamed ViewStation) 2. Product Information: a. Product Name ViewS…	Impac Medical Systems, Inc.	1995	—

Also cleared against K942346: 2 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K043412	Modification to: Viewstation	Impac Medical Systems, Inc.	2004	9

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?

Its one ancestor has no recall.
Of its descendants, K043412 (Impac Medical Systems, Inc., 2004) has gone furthest, with 9 descendants of its own.
2 other devices also cite its predicate K942346.

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?

ViewStation supports image and information flow among health care facility personnel. ViewStation can be used whenever digital images and associated data are the means for communicating information. ViewStation is not intended for use in diagnosis.

The intended use of ViewStation is to provide health care facility personnel with an efficient and effective means to utilize patient images during the course of therapy or treatment. ViewStation allows users to import, view, annotate, manipulate, enhance, manage, and archive patient images. The images and associated information are stored in a database, providing users access to the information necessary to perform their functions.

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/K011694 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011694: Viewstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011694

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026