510(k) · Cleared

Cleared

Paxscan 4030 Medical Digital Imaging System

K024147510(k) TraditionalCleared Feb 12, 200358-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

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

Cleared on Feb 12, 2003 as substantially equivalent to K982795 (Philips Medical Systems, Inc., 1998) and 3 other predicates after a 58-day review. Its family tree reaches back 4 generations to 1981. 78 later devices descend from it.

Decided: Feb 12, 2003
Review: 58 days
Class: Class II
Product code: MQB
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K803130 (1981). 16 ancestors in all. 78 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 4 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
3 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
2 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
1 generation backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
This deviceK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
Descendant · cites it directly · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
Descendant · cites it directly · 30 of its ownK120020 Vivix-SVieworks Co., Ltd. · 2012
Descendant · 2 generations on · 28 of its ownK122865 Vivix-S WirelessVieworks Co., Ltd. · 2013
Descendant · 2 generations on · 25 of its ownK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
Descendant · 3 generations on · 15 of its ownK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2007high 9 (2021) · low 1 (2007)2026

Most influential descendants

Showing 5 of 78 · See all

K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · cites it directly34descendants
K120020Vivix-SVieworks Co., Ltd. · 2012 · cites it directly30descendants
K122865Vivix-S WirelessVieworks Co., Ltd. · 2013 · 2 generations on28descendants
K122736DX-D Imaging PackageAgfa Healthcare N.V. · 2013 · 2 generations on25descendants
K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014 · 3 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K803130	Multix U. Bucky Table X-Ray Unit	Siemens Corp.	1981	1
−3	K971452	Multix Top/Pro Radiographic X-Ray Table	Siemens Medical Solutions USA, Inc.	1997	8
−2	K983732	Thorax FD and Multix FD	Siemens Medical Solutions USA, Inc.	1999	1
−1	K992794	Stingray DR, Model 1	Infimed, Inc.	1999	—
0 (this device)	K024147	Paxscan 4030 Medical Digital Imaging System	Varian Medical Systems, Inc.	2003	—
+1	K092669	DX-D Imaging Package	Agfa Healthcare N.V.	2009	1
+1	K120020	Vivix-S	Vieworks Co., Ltd.	2012	—
+2	K122865	Vivix-S Wireless	Vieworks Co., Ltd.	2013	—
+2	K122736	DX-D Imaging Package	Agfa Healthcare N.V.	2013	—
+3	K140771	Philips Eleva Workspot	Philips Medical Systems Dmc GmbH	2014	—

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
1995	2	0
1997	1	0
1998	3	0
2000	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K024147, 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 1 …ky Canon X-Ray Fugi CR Infimed Vision Digital Camera System Stringray DR 510(K) Numbers: K982795 K981556 K993861 K992794 Common Name: Solid State X-Ray Imager Regulatory Class:…	Philips Medical Systems, Inc.	1998	17
*	K981556	Canon X-Ray Digital Camera Cxdi-11 Summary page 1 …gi CR Infimed Vision Digital Camera System Stringray DR 510(K) Numbers: K982795 K981556 K993861 K992794 Common Name: Solid State X-Ray Imager Regulatory Class: Class 11,…	Canon USA, Inc.	1998	—
*	K993861	Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader Summary page 1 …imed Vision Digital Camera System Stringray DR 510(K) Numbers: K982795 K981556 K993861 K992794 Common Name: Solid State X-Ray Imager Regulatory Class: Class 11, 21 CFR 892.- /…	Fujifilm Medical System U.S.A., Inc.	2000	1
*	K992794	Stingray DR, Model 1 Summary page 1 …Vision Digital Camera System Stringray DR 510(K) Numbers: K982795 K981556 K993861 K992794 Common Name: Solid State X-Ray Imager Regulatory Class: Class 11, 21 CFR 892.- /630 Panel:…	Infimed, Inc.	1999	—

Also cleared against K982795: 10 other devices →

What descends from it? (78)

See all 78

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

Number	Device	Applicant	Decided	Descendants
K092669	DX-D Imaging Package	Agfa Healthcare N.V.	2009	34
K120020	Vivix-S	Vieworks Co., Ltd.	2012	30
K083645	Radstar Family, Models: Radstar 4343 & Variations	5 Star Medical, Inc.	2009	6
K080742	Verisuite 1.6, Verisuite-Particle 1.6	Medcom GmbH	2008	5
K111312	Santeview	Sehyun Co., Ltd.	2011	0
K072766	Pvmed DDR 2520 Digital Imaging System	Portavision Medical	2007	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 22 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
10 of the 16 ancestors have a recall of any class.
Of its descendants, K092669 (Agfa Healthcare N.V., 2009) has gone furthest, with 34 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 PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view.

This device is intended for use by qualified medical personnel trained in radiology

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024147 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024147: Paxscan 4030 Medical Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024147

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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