510(k) · Cleared

Recalled · 2011

EOS

K071546510(k) TraditionalCleared Sep 18, 2007104-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

Biospace Med · KPR System, X-Ray, Stationary

Cleared on Sep 18, 2007 as substantially equivalent to K013999 (Lodox Systems (Pty), Ltd., 2002) and 6 other predicates after a 104-day review. Its family tree reaches back 3 generations to 1981. 7 later devices descend from it. It has been recalled once.

Decided: Sep 18, 2007
Review: 104 days
Class: Class II
Product code: KPR
Recalls: 1
Predicates: 7

Its longest line of descent runs back 3 generations to K803130 (1981). 14 ancestors in all, the oldest K790692 (1979). 7 later devices descend from it, 2 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 deviceK071546 EOSBiospace Med · 2007
Descendant · cites it directly · 6 of its ownK120721 EOSEos Imaging · 2012
Descendant · cites it directly · 5 of its ownK123740 EOSEos Imaging · 2013 · Recalled
Descendant · 2 generations on · 4 of its ownK142773 EOS SystemEos Imaging · 2015
Descendant · 3 generations on · 3 of its ownK152788 EOS SystemEos Imaging · 2015
Descendant · 4 generations on · 2 of its ownK192079 EOSedgeEos Imaging · 2019

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012high 2 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all

K120721EOSEos Imaging · 2012 · cites it directly6descendants
K123740EOSEos Imaging · 2013 · cites it directly5descendants
K142773EOS SystemEos Imaging · 2015 · 2 generations on4descendants
K152788EOS SystemEos Imaging · 2015 · 3 generations on3descendants
K192079EOSedgeEos Imaging · 2019 · 4 generations on2descendants

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)	K071546	EOS	Biospace Med	2007	—
+1	K120721	EOS	Eos Imaging	2012	—
+1	K123740	EOS	Eos Imaging	2013	1
+2	K142773	EOS System	Eos Imaging	2015	—
+3	K152788	EOS System	Eos Imaging	2015	—
+4	K192079	EOSedge	Eos Imaging	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1984	1	0
1988	1	0
1989	1	0
1992	1	0
1994	2	0
1995	1	0
1997	1	0
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	2	0
2019	1	0
2020	1	0
2024	1	0

FIG. 1 — Lineage of K071546, 1981–2024Source: 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? (7)

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
*	K013999	Lodox, Model Baseline Summary page 1 …une 5, 2007 Trade Name: EOS Common or Usual Name: Digital Radiography System Classification Name: Radiology \| Predicate Devices The Lodox Digital Radiography System {K013999) Toshiba’s Auklet CT scanner TSX-003-A (K973908) GE Televix 1600 (K790692) with AGFA Cornex 5 fim Philips Bucky Diagnost Syste…	Lodox Systems (Pty), Ltd.	2002	—
*	K973908	Auklet CT Scanner, TSX-003A Summary page 1 …e: Digital Radiography System Classification Name: Radiology \| Predicate Devices The Lodox Digital Radiography System {K013999) Toshiba’s Auklet CT scanner TSX-003-A (K973908) GE Televix 1600 (K790692) with AGFA Cornex 5 fim Philips Bucky Diagnost System {K945278) with AGFA Curix-Ortho HT-G film CGR P…	Toshiba America Medical Systems, In.C	1997	—
*	K790692	Televix Summary page 1 …em Classification Name: Radiology \| Predicate Devices The Lodox Digital Radiography System {K013999) Toshiba’s Auklet CT scanner TSX-003-A (K973908) GE Televix 1600 (K790692) with AGFA Cornex 5 fim Philips Bucky Diagnost System {K945278) with AGFA Curix-Ortho HT-G film CGR Prestilix (K843926) + Kodak…	General Electrical Espanola, S.A.	1979	1
*	K945278	Philips Bucky Diagnost Family Summary page 1 …x Digital Radiography System {K013999) Toshiba’s Auklet CT scanner TSX-003-A (K973908) GE Televix 1600 (K790692) with AGFA Cornex 5 fim Philips Bucky Diagnost System {K945278) with AGFA Curix-Ortho HT-G film CGR Prestilix (K843926) + Kodak DirectView CR 900 System (K020635) Siemens DR Thorax/Multix FD (…	Philips Medical Systems North America, Inc.	1994	10
*	K843926	Prestilix 1690 Summary page 1 …CT scanner TSX-003-A (K973908) GE Televix 1600 (K790692) with AGFA Cornex 5 fim Philips Bucky Diagnost System {K945278) with AGFA Curix-Ortho HT-G film CGR Prestilix (K843926) + Kodak DirectView CR 900 System (K020635) Siemens DR Thorax/Multix FD (K983732) * [ e L] * L Intended Use / Indications for U…	Cgr Medical Corp.	1984	—
*	K020635	Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System… Summary page 1 …1600 (K790692) with AGFA Cornex 5 fim Philips Bucky Diagnost System {K945278) with AGFA Curix-Ortho HT-G film CGR Prestilix (K843926) + Kodak DirectView CR 900 System (K020635) Siemens DR Thorax/Multix FD (K983732) * [ e L] * L Intended Use / Indications for Use The EOS is intended for use in general…	Eastman Kodak Company	2002	1
*	K983732	Thorax FD and Multix FD Summary page 1 …Philips Bucky Diagnost System {K945278) with AGFA Curix-Ortho HT-G film CGR Prestilix (K843926) + Kodak DirectView CR 900 System (K020635) Siemens DR Thorax/Multix FD (K983732) * [ e L] * L Intended Use / Indications for Use The EOS is intended for use in general radiographic examinations and applicat…	Siemens Medical Solutions USA, Inc.	1999	1

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K120721	EOS	Eos Imaging	2012	6
K123740	EOS	Eos Imaging	2013	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 13, 2011	Not classified	Z-2692-2011	Software design	Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
7 of the 14 ancestors have a recall of any class.
Of its descendants, K120721 (Eos Imaging, 2012) has gone furthest, with 6 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. 2007, 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 EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.

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/K071546 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071546: EOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071546

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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

EOS