510(k) · Cleared

Cleared

Stingray DR, Model 1

K992794510(k) TraditionalCleared Nov 9, 199982-day reviewClass II21 CFR 892.1680

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

Infimed, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Nov 9, 1999 as substantially equivalent to K982795 (Philips Medical Systems, Inc., 1998) and 3 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1981. 103 later devices descend from it.

Decided: Nov 9, 1999
Review: 82 days
Class: Class II
Product code: MQB
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K803130 (1981). 12 ancestors in all. 103 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
2 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
1 generation backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
This deviceK992794 Stingray DR, Model 1Infimed, Inc. · 1999
Descendant · cites it directly · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
Descendant · 2 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
Descendant · 2 generations on · 30 of its ownK120020 Vivix-SVieworks Co., Ltd. · 2012
Descendant · 3 generations on · 28 of its ownK122865 Vivix-S WirelessVieworks Co., Ltd. · 2013
Descendant · 3 generations on · 25 of its ownK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2003high 9 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 103 · See all

K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · cites it directly78descendants
K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 2 generations on34descendants
K120020Vivix-SVieworks Co., Ltd. · 2012 · 2 generations on30descendants
K122865Vivix-S WirelessVieworks Co., Ltd. · 2013 · 3 generations on28descendants
K122736DX-D Imaging PackageAgfa Healthcare N.V. · 2013 · 3 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K803130	Multix U. Bucky Table X-Ray Unit	Siemens Corp.	1981	1
−2	K971452	Multix Top/Pro Radiographic X-Ray Table	Siemens Medical Solutions USA, Inc.	1997	8
−1	K983732	Thorax FD and Multix FD	Siemens Medical Solutions USA, Inc.	1999	1
0 (this device)	K992794	Stingray DR, Model 1	Infimed, Inc.	1999	—
+1	K024147	Paxscan 4030 Medical Digital Imaging System	Varian Medical Systems, Inc.	2003	—
+2	K092669	DX-D Imaging Package	Agfa Healthcare N.V.	2009	1
+2	K120020	Vivix-S	Vieworks Co., Ltd.	2012	—
+3	K122865	Vivix-S Wireless	Vieworks Co., Ltd.	2013	—
+3	K122736	DX-D Imaging Package	Agfa Healthcare N.V.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1988	1	0
1992	1	0
1994	2	0
1997	1	0
1998	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2007	1	0
2008	1	0
2009	3	0
2010	4	0
2011	6	0
2012	4	0
2013	7	0
2014	8	0
2015	5	0
2016	8	0
2017	9	0
2018	3	0
2019	8	0
2020	4	0
2021	9	0
2022	5	0
2023	4	0
2024	2	0
2025	5	0
2026	5	0

FIG. 1 — Lineage of K992794, 1981–2026Source: 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 MQB? 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 MQB device

#1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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? (4)

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
*	K982795	Philips Bucky Vision Summary page 2 …ID Feature/Item InfiMed Stingray \| Phillips Digital Siemens: Canon Digital GE Revolution DR Diagnost THORAX FD and \| Radiography XQri MULTIX FD System 510(k) number N/A K982795 K983732 K981556 K982196 Flat Panel Trixell Trixell Trixell Canon GE Producer Detector Material a-Si sensor array a-Si sensor a…	Philips Medical Systems, Inc.	1998	17
*	K983732	Thorax FD and Multix FD Summary page 2 …ure/Item InfiMed Stingray \| Phillips Digital Siemens: Canon Digital GE Revolution DR Diagnost THORAX FD and \| Radiography XQri MULTIX FD System 510(k) number N/A K982795 K983732 K981556 K982196 Flat Panel Trixell Trixell Trixell Canon GE Producer Detector Material a-Si sensor array a-Si sensor array a-…	Siemens Medical Solutions USA, Inc.	1999	1
*	K981556	Canon X-Ray Digital Camera Cxdi-11 Summary page 2 …InfiMed Stingray \| Phillips Digital Siemens: Canon Digital GE Revolution DR Diagnost THORAX FD and \| Radiography XQri MULTIX FD System 510(k) number N/A K982795 K983732 K981556 K982196 Flat Panel Trixell Trixell Trixell Canon GE Producer Detector Material a-Si sensor array a-Si sensor array a-Si senso…	Canon USA, Inc.	1998	—
*	K982196	Digital Radiographic Imaging System Summary page 2 …Stingray \| Phillips Digital Siemens: Canon Digital GE Revolution DR Diagnost THORAX FD and \| Radiography XQri MULTIX FD System 510(k) number N/A K982795 K983732 K981556 K982196 Flat Panel Trixell Trixell Trixell Canon GE Producer Detector Material a-Si sensor array a-Si sensor array a-Si sensor array…	GE Medical Systems	1998	—

Also cleared against K982795: 10 other devices →

What descends from it? (103)

See all 103

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

Number	Device	Applicant	Decided	Descendants
K024147	Paxscan 4030 Medical Digital Imaging System	Varian Medical Systems, Inc.	2003	78
K093066	I5 Digital X-Ray Imaging System, Model I5	Infimed, Inc.	2010	22
K161459	Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)	Varian Medical Systems, X-Ray Products-Infimed	2016	5
K052661	Quix Digital Radiographic Upgrade	Edge Medical Devices, Ltd.	2006	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?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
8 of the 12 ancestors have a recall of any class.
Of its descendants, K024147 (Varian Medical Systems, Inc., 2003) has gone furthest, with 78 descendants of its own.
10 other devices also cite its predicate K982795.

How does its category compare?

All MQB devices

MQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQB

8in 2025

2007high 32 (2014) · low 8 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQB

127in 2025

2007high 245 (2026) · low 15 (2008)2026

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

Recalls per year · MQB

1in 2025

2007high 36 (2008) · low 0 (2014)2026

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

Adverse event reports per year · MQB

141in 2025

2007high 267 (2012) · low 9 (2020)2025

MAUDE reports naming product code MQB, 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	13	22	15	25
2008	8	15	36	30
2009	15	57	19	34
2010	11	116	14	39
2011	24	102	10	101
2012	22	80	8	267
2013	21	105	6	159
2014	32	102	0	29
2015	21	81	0	21
2016	22	92	0	26
2017	31	30	1	20
2018	16	30	4	84
2019	22	30	1	45
2020	19	28	4	9
2021	21	48	1	26
2022	31	48	0	13
2023	10	30	0	51
2024	8	187	0	91
2025	8	127	1	141
2026	3	245	1	—

What is it indicated for?

The Stingray Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

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/K992794 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992794: Stingray DR, Model 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992794

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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