510(k) · Cleared

Recalled · Class II · 2015

DRX-Evolution

K141837510(k) TraditionalCleared Mar 11, 2015247-day reviewClass II21 CFR 892.1680Recalls 1

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

Carestream Health, Inc. · KPR System, X-Ray, Stationary

Cleared on Mar 11, 2015 as substantially equivalent to K091889 (Carestream Health, Inc., 2009) after a 247-day review. Its family tree reaches back 3 generations to 2002. 29 later devices descend from it. It has been recalled once.

Decided: Mar 11, 2015
Review: 247 days
Class: Class II
Product code: KPR
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K020635 (2002). 4 ancestors in all. 29 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK020635 Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview…Eastman Kodak Company · 2002 · Recalled
2 generations backK090318 Carestream DRX-1 SystemCarestream Health, Inc. · 2009 · Recalled
1 generation backK091889 DRX-Evolution, Model VX3733-SysCarestream Health, Inc. · 2009 · Recalled
This deviceK141837 DRX-EvolutionCarestream Health, Inc. · 2015
Descendant · cites it directly · 26 of its ownK160997 GC85ASamsung Electronics Co., Ltd. · 2016
Descendant · 2 generations on · 23 of its ownK163115 GC70Samsung Electronics Co., Ltd. · 2016
Descendant · 2 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
Descendant · 3 generations on · 22 of its ownK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
Descendant · 2 generations on · 21 of its ownK172229 GC85ASamsung Electronics Co., Ltd. · 2017

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2016high 8 (2018) · low 1 (2023)2026

Most influential descendants

Showing 5 of 29 · See all

K160997GC85ASamsung Electronics Co., Ltd. · 2016 · cites it directly26descendants
K163115GC70Samsung Electronics Co., Ltd. · 2016 · 2 generations on23descendants
K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 2 generations on23descendants
K171119GM85Samsung Electronics Co., Ltd. · 2017 · 3 generations on22descendants
K172229GC85ASamsung Electronics Co., Ltd. · 2017 · 2 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K020635	Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900…	Eastman Kodak Company	2002	1
−2	K090318	Carestream DRX-1 System	Carestream Health, Inc.	2009	2
−1	K091889	DRX-Evolution, Model VX3733-Sys	Carestream Health, Inc.	2009	3
0 (this device)	K141837	DRX-Evolution	Carestream Health, Inc.	2015	—
+1	K160997	GC85A	Samsung Electronics Co., Ltd.	2016	—
+2	K163115	GC70	Samsung Electronics Co., Ltd.	2016	—
+2	K162278	Digital Diagnostic Mobile X-ray System	Samsung Electronics Co., Ltd.	2016	—
+3	K171119	GM85	Samsung Electronics Co., Ltd.	2017	1
+2	K172229	GC85A	Samsung Electronics Co., Ltd.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	3	0
2017	2	0
2018	8	0
2019	2	0
2020	2	0
2021	2	0
2022	2	0
2023	1	0
2024	4	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K141837, 2002–2026Source: 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 KPR? 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 KPR device

#1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K091889	DRX-Evolution, Model VX3733-Sys Summary page 4 …ce: Carestream DRX-Evolution Manufactured by Carestream Health, Inc. 510(k) No. K091889 (July 20, 2009) Regulation No. 21 CFR 892.1680 Product Co…	Carestream Health, Inc.	2009	3
†	K944967	Tomo-Link	GE Medical Systems	1994	—

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K160997	GC85A	Samsung Electronics Co., Ltd.	2016	26
K201825	MiniCAT 2D	Xoran Technologies, LLC	2020	0
K191879	DRX-Evolution with Carestream Digital Tomosynthesis	Carestream Health, Inc.	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 7, 2015	Class II	Z-2449-2015	Software design	Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
4 of the 4 ancestors have a recall of any class.
Of its descendants, K160997 (Samsung Electronics Co., Ltd., 2016) has gone furthest, with 26 descendants of its own.

How does its category compare?

All KPR devices

KPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · KPR

8in 2025

2007high 18 (2015) · low 5 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPR

155in 2025

2007high 197 (2026) · low 30 (2018)2026

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

Recalls per year · KPR

7in 2025

2007high 10 (2007) · low 0 (2021)2026

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

Adverse event reports per year · KPR

39in 2025

2007high 120 (2007) · low 18 (2016)2025

MAUDE reports naming product code KPR, 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	12	31	10	120
2008	15	48	10	95
2009	9	35	5	61
2010	9	126	3	82
2011	9	152	5	103
2012	11	58	1	74
2013	5	163	5	24
2014	10	108	8	34
2015	18	81	1	59
2016	11	84	4	18
2017	6	75	3	31
2018	15	30	4	36
2019	12	33	1	77
2020	16	39	1	41
2021	6	55	0	37
2022	8	43	2	27
2023	9	76	4	39
2024	11	162	1	34
2025	8	155	7	39
2026	6	197	0	—

What is it indicated for?

The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141837: DRX-Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141837

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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