510(k) · Cleared

Cleared

Tigerscan/Tigerview

K955237510(k) TraditionalCleared Apr 4, 1996142-day reviewClass I21 CFR 892.2010

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

Tau Corp. · LMB Device, Digital Image Storage, Radiological

Cleared on Apr 4, 1996 as substantially equivalent to K930527 (Escan, Inc., 1993) after a 142-day review. Its family tree reaches back 1 generation to 1993. 83 later devices descend from it.

Decided: Apr 4, 1996
Review: 142 days
Class: Class I
Product code: LMB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K930527 (1993). 83 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK930527 Dental LinkEscan, Inc. · 1993
This deviceK955237 Tigerscan/TigerviewTau Corp. · 1996
Descendant · cites it directly · 63 of its ownK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
Descendant · 2 generations on · 36 of its ownK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
Descendant · 2 generations on · 35 of its ownK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
Descendant · cites it directly · 28 of its ownK061035 Tigerview ProfessionalTelevere Systems · 2006
Descendant · 2 generations on · 25 of its ownK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005

Showing 5 of 83 descendants. See all descendants

Descendants cleared per year

1997high 9 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 83 · See all

K012439Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002 · cites it directly63descendants
K050744Kavo Ergocom/ErgocamKavo America Corporation · 2005 · 2 generations on36descendants
K060178Vix Win ProGendex Dental Systems · 2006 · 2 generations on35descendants
K061035Tigerview ProfessionalTelevere Systems · 2006 · cites it directly28descendants
K043104Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005 · 2 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930527	Dental Link	Escan, Inc.	1993	—
0 (this device)	K955237	Tigerscan/Tigerview	Tau Corp.	1996	—
+1	K012439	Dentaleye 2 Dental Image Management System	Radco Data AB	2002	—
+2	K050744	Kavo Ergocom/Ergocam	Kavo America Corporation	2005	—
+2	K060178	Vix Win Pro	Gendex Dental Systems	2006	1
+1	K061035	Tigerview Professional	Televere Systems	2006	—
+2	K043104	Kodak Orthodontic Imaging and Oms Imaging 8.0	Practiceworks, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	1	0
2002	1	0
2005	3	0
2006	2	0
2007	3	0
2009	2	0
2010	1	0
2011	2	0
2012	1	0
2013	2	0
2014	3	0
2015	1	0
2016	3	0
2017	5	0
2018	2	0
2019	3	0
2020	6	0
2021	5	0
2022	6	0
2023	7	0
2024	6	0
2025	9	0
2026	7	0

FIG. 1 — Lineage of K955237, 1993–2026Source: 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 LMB? 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? (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
*	K930527	Dental Link Summary page 1 …ntact Person: John Thomas APR ~ 4 1996 Uate Prepared: 4 October 1995 9.2 Device Name: TigerScan / TigerView 9.3 Equivalent Device: Dental Link, FDA registration number K930527/A 9.4 Device Description TigerScan and TigerView are software packages designed to run on industry standard PC- compatible comp…	Escan, Inc.	1993	—

What descends from it? (83)

See all 83

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012439	Dentaleye 2 Dental Image Management System	Radco Data AB	2002	63
K061035	Tigerview Professional	Televere Systems	2006	28
K082623	Visix Imaging	Televere Systems	2009	9
K983111	Xray Vision	Apteryx, Inc.	1998	1
K973476	Kodak Digital Science-Dental Image Viewer	Eastman Kodak Company	1997	0
K971894	Kodak Digital Science - Dental Scanning System	Eastman Kodak Company	1997	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?

Its one ancestor has no recall.
Of its descendants, K012439 (Radco Data AB, 2002) has gone furthest, with 63 descendants of its own.

How does its category compare?

All LMB devices

LMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMB

FDA has decided no LMB device since 2007.

Median 510(k) review, days · LMB

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

Recalls per year · LMB

1in 2013

2007high 5 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LMB

7in 2025

2007high 21 (2016) · low 0 (2015)2025

MAUDE reports naming product code LMB, 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	—	0	1
2008	—	1	3
2009	—	5	3
2010	—	0	16
2011	—	2	4
2012	—	0	4
2013	—	1	7
2014	—	0	1
2015	—	0	0
2016	—	0	21
2017	—	0	10
2018	—	0	5
2019	—	0	10
2020	—	0	8
2021	—	0	10
2022	—	0	0
2023	—	0	10
2024	—	0	9
2025	—	0	7
2026	—	0	—

What is it indicated for?

Uses for TigerScan and TigerView in the dental industry include the following: - Scanning of film and archival storage for on-line access by patient. - Electronic transmission of digital radiographs with insurance claims. - Radiograph viewing and manipulation for Insurance claims adjudication - Radiograph viewing and manipulation for diagnostic purposes. - Radiograph viewing for patient education and consultation. - Electronic transmission of radiographs…

Read the full statement (123 words)

Uses for TigerScan and TigerView in the dental industry include the following:

- Scanning of film and archival storage for on-line access by patient.

- Electronic transmission of digital radiographs with insurance claims.

- Radiograph viewing and manipulation for Insurance claims adjudication

- Radiograph viewing and manipulation for diagnostic purposes.

- Radiograph viewing for patient education and consultation.

- Electronic transmission of radiographs to specialists for consultation.

When used for diagnostic purposes, the patient population will be the general public, and the diseases / conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.

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/K955237 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955237: Tigerscan/Tigerview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955237

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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