510(k) · Cleared

Cleared

Koordinant Angiographic and Operating Room Model X-Ray Table Family

K993947510(k) TraditionalCleared Dec 21, 199929-day reviewClass II21 CFR 892.1600

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

Siemens Corp. · IZI System, X-Ray, Angiographic

Cleared on Dec 21, 1999 as substantially equivalent to K951176 (Siemens Medical Solutions USA, Inc., 1995) and 3 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1988.

Decided: Dec 21, 1999
Review: 29 days
Class: Class II
Product code: IZI
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K883613 (1988). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK883613 Oper. Table for Percutan. Trans. Coronary Angio.Stierlen-Maquet AG · 1988
This deviceK993947 Koordinant Angiographic and Operating Room Model X-Ray Table FamilySiemens Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K883613	Oper. Table for Percutan. Trans. Coronary Angio.	Stierlen-Maquet AG	1988	—
0 (this device)	K993947	Koordinant Angiographic and Operating Room Model X-Ray Table Family	Siemens Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1994	1	0
1995	1	0

FIG. 1 — Lineage of K993947, 1988–1999Source: 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 IZI? 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 IZI device

#1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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? (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
*	K951176	Koordinat M Summary page 1 …required. 4. Substantial Equivalence: The new Koordinat OR models are substantially equivalent to the following device in commercial distribution: o Koordinat M Table, K951176 cleared on 4/30/95 Siemens Medical Systems, Inc. e OP/PTCA-System 1520, K883613 cleared on 9/15/88 Magquet o Synchra Tilt, K940…	Siemens Medical Solutions USA, Inc.	1995	—
*	K883613	Oper. Table for Percutan. Trans. Coronary Angio. Summary page 1 …lly equivalent to the following device in commercial distribution: o Koordinat M Table, K951176 cleared on 4/30/95 Siemens Medical Systems, Inc. e OP/PTCA-System 1520, K883613 cleared on 9/15/88 Magquet o Synchra Tilt, K940696 cleared on Philips ¢ 90/50 Mobile Imaging Table, K884531 cleared onl1/11/89…	Stierlen-Maquet AG	1988	—
*	K940696	Syncra Tilt Option for Angio Diagnost 5 Summary page 1 …distribution: o Koordinat M Table, K951176 cleared on 4/30/95 Siemens Medical Systems, Inc. e OP/PTCA-System 1520, K883613 cleared on 9/15/88 Magquet o Synchra Tilt, K940696 cleared on Philips ¢ 90/50 Mobile Imaging Table, K884531 cleared onl1/11/89 Beta Medical System 510 (k) for Siemens Koordinat A…	Philips Medical Systems North America, Inc.	1994	—
*	K884531	Beta 90/50 Mobile Imaging Table Summary page 1 …30/95 Siemens Medical Systems, Inc. e OP/PTCA-System 1520, K883613 cleared on 9/15/88 Magquet o Synchra Tilt, K940696 cleared on Philips ¢ 90/50 Mobile Imaging Table, K884531 cleared onl1/11/89 Beta Medical System 510 (k) for Siemens Koordinat Angiographic X-Ray Table Family — OR Models Page 38 of 40…	Beta Medical Products Co.	1989	—

Also cleared against K951176: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 4 ancestors has a recall.
1 other device also cites its predicate K951176.

How does its category compare?

All IZI devices

IZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZI

2in 2025

2007high 7 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZI

81in 2023

2007high 111 (2014) · low 28 (2007)2026

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

Recalls per year · IZI

1in 2021

2007high 52 (2008) · low 0 (2022)2026

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

Adverse event reports per year · IZI

2,171in 2025

2007high 2,171 (2025) · low 14 (2020)2025

MAUDE reports naming product code IZI, 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	7	28	6	92
2008	6	68	52	101
2009	2	—	18	132
2010	2	—	11	252
2011	4	104	6	377
2012	1	—	6	77
2013	1	—	6	58
2014	4	111	5	123
2015	0	—	14	36
2016	1	—	7	102
2017	2	—	1	88
2018	2	—	2	49
2019	2	—	2	30
2020	1	—	2	14
2021	1	—	1	29
2022	1	—	0	265
2023	3	81	0	1,204
2024	2	—	0	1,332
2025	2	—	0	2,171
2026	2	—	1	—

What is it indicated for?

The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

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/K993947 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993947: Koordinant Angiographic and Operating Room Model X-Ray Table Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993947

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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