510(k) · Cleared

Cleared

Accent

K050693510(k) TraditionalCleared May 26, 200570-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

Air Techniques, Inc. · MUH System, X-Ray, Extraoral Source, Digital

Cleared on May 26, 2005 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 55 later devices descend from it.

Decided: May 26, 2005
Review: 70 days
Class: Class II
Product code: MUH
Recalls: None
Predicates: 0

55 later devices descend from it, 5 citing it directly.

This deviceK050693 AccentAir Techniques, Inc. · 2005
Descendant · cites it directly · 44 of its ownK070505 Krystal-X WifiOwandy · 2007
Descendant · 2 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
Descendant · 3 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
Descendant · 3 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Descendant · 4 generations on · 18 of its ownK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2006high 6 (2019) · low 0 (2013)2026

Most influential descendants

Showing 5 of 55 · See all

K070505Krystal-X WifiOwandy · 2007 · cites it directly44descendants
K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on43descendants
K121513Multix FusionSiemens Medical Solution · 2012 · 3 generations on32descendants
K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on23descendants
K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014 · 4 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K050693	Accent	Air Techniques, Inc.	2005	—
+1	K070505	Krystal-X Wifi	Owandy	2007	—
+2	K081722	YSIO	Siemens Medical Solutions USA, Inc.	2008	11
+3	K121513	Multix Fusion	Siemens Medical Solution	2012	4
+3	K133259	Ysio Max	Siemens Medical Solutions USA, Inc.	2014	7
+4	K142049	Multix Fusion VA30 & VA40	Siemens Medical Solutions USA, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	2	0
2009	2	0
2010	2	0
2011	2	0
2012	1	0
2014	3	0
2015	2	0
2016	3	0
2017	1	0
2018	3	0
2019	6	0
2020	4	0
2021	3	0
2022	4	0
2023	4	0
2024	3	0
2025	5	0
2026	3	0

FIG. 1 — Lineage of K050693, 2005–2026Source: 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? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K070505	Krystal-X Wifi	Owandy	2007	44
K061114	WDS, Size 2 and Size 2	Cefla S.C.R.L.	2006	5
K080738	Dentron Sensor	Dentron Systems, LLC	2008	3
K092547	Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control Box	Dentimax	2009	2
K092329	SOPIX 2	Sopro	2010	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, K070505 (Owandy, 2007) has gone furthest, with 44 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 Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant X-ray images, typically of teeth, bone and surrounding tissues.

Accent replaces standard X-ray film and/or phosphor plate technology.

The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.

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

https://510kreport.com/device/K050693 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050693: Accent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050693

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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