510(k) · Cleared

Recalled · Class II · 2014

Kodak Directview DR 7500 System, Model 8791345

K051258510(k) SpecialCleared Jun 1, 200516-day reviewClass II21 CFR 892.1680Recalls 4

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

Eastman Kodak Company · KPR System, X-Ray, Stationary

Cleared on Jun 1, 2005 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 32 later devices descend from it. It has been recalled 4 times.

Decided: Jun 1, 2005
Review: 16 days
Class: Class II
Product code: KPR
Recalls: 4
Predicates: 0

32 later devices descend from it, 2 citing it directly.

This deviceK051258 Kodak Directview DR 7500 System, Model 8791345Eastman Kodak Company · 2005
Descendant · cites it directly · 30 of its ownK091889 DRX-Evolution, Model VX3733-SysCarestream Health, Inc. · 2009 · Recalled
Descendant · 2 generations on · 29 of its ownK141837 DRX-EvolutionCarestream Health, Inc. · 2015 · Recalled
Descendant · 3 generations on · 26 of its ownK160997 GC85ASamsung Electronics Co., Ltd. · 2016
Descendant · 4 generations on · 23 of its ownK163115 GC70Samsung Electronics Co., Ltd. · 2016
Descendant · 4 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2009high 8 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 32 · See all

K091889DRX-Evolution, Model VX3733-SysCarestream Health, Inc. · 2009 · cites it directly30descendants
K141837DRX-EvolutionCarestream Health, Inc. · 2015 · 2 generations on29descendants
K160997GC85ASamsung Electronics Co., Ltd. · 2016 · 3 generations on26descendants
K163115GC70Samsung Electronics Co., Ltd. · 2016 · 4 generations on23descendants
K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 4 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K051258	Kodak Directview DR 7500 System, Model 8791345	Eastman Kodak Company	2005	—
+1	K091889	DRX-Evolution, Model VX3733-Sys	Carestream Health, Inc.	2009	3
+2	K141837	DRX-Evolution	Carestream Health, Inc.	2015	1
+3	K160997	GC85A	Samsung Electronics Co., Ltd.	2016	—
+4	K163115	GC70	Samsung Electronics Co., Ltd.	2016	—
+4	K162278	Digital Diagnostic Mobile X-ray System	Samsung Electronics Co., Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	1	0
2015	1	0
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 K051258, 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 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

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? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K091889	DRX-Evolution, Model VX3733-Sys	Carestream Health, Inc.	2009	30
K133695	TITAN 11	Gemss Medical Systems Co., Ltd.	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 9, 2014	Class II	Z-2177-2014	Device Design	An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts…
Dec 26, 2013	Class II	Z-0844-2014	Software Manufacturing/Software Deployment	Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
Nov 25, 2013	Class II	Z-0798-2014	Nonconforming Material/Component	Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
Mar 6, 2007	Not classified	Z-0738-2007	Other	The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K091889 (Carestream Health, Inc., 2009) has gone furthest, with 30 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.

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 KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K051258 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051258: Kodak Directview DR 7500 System, Model 8791345.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051258

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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