510(k) · Cleared

Cleared

Stentor, Pageview

K992698510(k) TraditionalCleared Oct 25, 199975-day reviewClass I21 CFR 892.2020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stentor, Inc. · LMD System, Digital Image Communications, Radiological

Cleared on Oct 25, 1999 as substantially equivalent to K982769 (Mitra Imaging, Inc., 1998) and 1 other predicate after a 75-day review. Its family tree reaches back 3 generations to 1996.

Decided: Oct 25, 1999
Review: 75 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K954678 (1996). 8 ancestors in all, the oldest K924178 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
2 generations backK971347 MedisurfInternational Regulatory Consultants · 1997
1 generation backK982769 Mitra Imaging Inc. ExhibitMitra Imaging, Inc. · 1998 · Recalled
This deviceK992698 Stentor, PageviewStentor, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K954678	Pro Vision	Algotec Systems, Ltd.	1996	—
−2	K971347	Medisurf	International Regulatory Consultants	1997	—
−1	K982769	Mitra Imaging Inc. Exhibit	Mitra Imaging, Inc.	1998	1
0 (this device)	K992698	Stentor, Pageview	Stentor, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0
1995	1	0
1997	1	0
1999	1	0

FIG. 1 — Lineage of K992698, 1996–1999Source: 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 LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K982769	Mitra Imaging Inc. Exhibit Summary page 2 …gy System Proprietary Name: Stentor PageView Substantial Equivalence The PageView software is substantially equivalent to the Mitra, Exhibit 1.6 1.7 (K982769) and the Dome Imaging Systems, PACScache (K983815). Device Description and Intended Use Stentor PageView is a digital medical i…	Mitra Imaging, Inc.	1998	1
*	K983815	Pacscache Summary page 2 …tantial Equivalence The PageView software is substantially equivalent to the Mitra, Exhibit 1.6 1.7 (K982769) and the Dome Imaging Systems, PACScache (K983815). Device Description and Intended Use Stentor PageView is a digital medical imaging distribution and display system to be used…	Dome Imaging Systems, Inc.	1999	—

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 3 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
1 of the 8 ancestors has a recall of any class.

How does its category compare?

All LMD devices

LMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMD

FDA has decided no LMD device since 2007.

Median 510(k) review, days · LMD

Too few LMD 510(k)s in any year since 2007 to give a median.

Recalls per year · LMD

2in 2020

2007high 2 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMD

16in 2025

2007high 16 (2025) · low 1 (2007)2025

MAUDE reports naming product code LMD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	1	2
2009	—	1	3
2010	—	0	9
2011	—	0	1
2012	—	1	2
2013	—	0	4
2014	—	0	12
2015	—	1	9
2016	—	0	3
2017	—	0	2
2018	—	0	4
2019	—	0	2
2020	—	2	2
2021	—	0	2
2022	—	0	6
2023	—	0	7
2024	—	0	8
2025	—	0	16
2026	—	0	—

What is it indicated for?

Stentor PageView is a digital medical imaging distribution and display system

to be used for both primary diagnosis and efficient distribution of medical

images within the healthcare enterprise. It operates on the conventional

TCP/IP internetworking infrastructure available in most healthcare

organizations, and it uses commercially available computer platforms (Intel

Pentium-based) and operating systems (Microsoft Windows NT, Windows 95,

and Windows 98). The system does not permanently store or produce

original medical images.

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/K992698 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992698: Stentor, Pageview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992698

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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