510(k) · Cleared

Cleared

Intraoral Imaging System, Model Suni-Ray

K021718510(k) TraditionalCleared Aug 15, 200284-day reviewClass II21 CFR 872.1800

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

Suni Imaging Microsystems, Inc. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on Aug 15, 2002 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 38 later devices descend from it.

Decided: Aug 15, 2002
Review: 84 days
Class: Class II
Product code: MUH
Recalls: None
Predicates: 0

38 later devices descend from it, 3 citing it directly.

This deviceK021718 Intraoral Imaging System, Model Suni-RaySuni Imaging Microsystems, Inc. · 2002
Descendant · cites it directly · 35 of its ownK070219 Suniray II Digital Radiography SystemSuni Medical Imaging, Inc. · 2007
Descendant · 2 generations on · 18 of its ownK090458 Dexis SensorDexis, LLC · 2009
Descendant · 2 generations on · 13 of its ownK103290 Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011
Descendant · 3 generations on · 11 of its ownK150823 EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
Descendant · 4 generations on · 10 of its ownK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2004high 7 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 38 · See all

K070219Suniray II Digital Radiography SystemSuni Medical Imaging, Inc. · 2007 · cites it directly35descendants
K090458Dexis SensorDexis, LLC · 2009 · 2 generations on18descendants
K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011 · 2 generations on13descendants
K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015 · 3 generations on11descendants
K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015 · 4 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021718	Intraoral Imaging System, Model Suni-Ray	Suni Imaging Microsystems, Inc.	2002	—
+1	K070219	Suniray II Digital Radiography System	Suni Medical Imaging, Inc.	2007	—
+2	K090458	Dexis Sensor	Dexis, LLC	2009	—
+2	K103290	Edlen Imaging - Gemini Dusb	Edlen Imaging, LLC	2011	—
+3	K150823	EDLENi Intra-Oral Sensor	Edlen Imaging, LLC	2015	—
+4	K151926	QuickRay HD Intraoral Sensor	Denterprise International, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2007	1	0
2009	1	0
2011	3	0
2012	1	0
2013	1	0
2014	1	0
2015	2	0
2016	2	0
2017	3	0
2018	2	0
2019	1	0
2020	2	0
2021	7	0
2022	2	0
2023	6	0
2024	1	0

FIG. 1 — Lineage of K021718, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MUH? 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 MUH device

#1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K070219	Suniray II Digital Radiography System	Suni Medical Imaging, Inc.	2007	35
K042736	CDX Digital X-Ray Imaging System	Cnc Imaging, Inc.	2004	0
K042372	HDS Intra-Oral Imaging System	Vatech Value Added Technology Co., Ltd.	2004	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?

Of its descendants, K070219 (Suni Medical Imaging, Inc., 2007) has gone furthest, with 35 descendants of its own.

How does its category compare?

All MUH devices

MUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUH

3in 2025

2007high 12 (2015) · low 3 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUH

159in 2025

2007high 174 (2010) · low 29 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUH

1in 2015

2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MUH

1in 2025

2007high 12 (2009) · low 0 (2007)2025

MAUDE reports naming product code MUH, 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	11	48	0	0
2008	8	64	1	0
2009	9	88	2	12
2010	9	174	0	9
2011	10	89	0	0
2012	9	81	0	5
2013	9	172	1	1
2014	8	168	1	5
2015	12	111	1	3
2016	6	47	0	1
2017	9	84	0	4
2018	3	29	0	10
2019	5	64	0	6
2020	5	36	0	0
2021	10	80	0	1
2022	7	57	0	0
2023	11	57	0	1
2024	4	144	0	0
2025	3	159	0	1
2026	2	—	0	—

What is it indicated for?

The Suni Digital Radiography System is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K021718 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021718: Intraoral Imaging System, Model Suni-Ray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021718

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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