510(k) · Cleared

Cleared

Opdima Digital Mammographic X-Ray System

K071015510(k) SpecialCleared May 10, 200730-day reviewClass II21 CFR 892.1720

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

Siemens Medical Solutions USA, Inc. · IZL System, X-Ray, Mobile

Cleared on May 10, 2007 as substantially equivalent to K003945 (Siemens Medical Solutions USA, Inc., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: May 10, 2007
Review: 30 days
Class: Class II
Product code: IZL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003945 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003945 OpdimaSiemens Medical Solutions USA, Inc. · 2001
This deviceK071015 Opdima Digital Mammographic X-Ray SystemSiemens Medical Solutions USA, Inc. · 2007
Descendant · cites it directly · 0 of its ownK072392 Opdima Digital Mammographic X-Ray SystemSiemens Medical Solutions USA, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K072392Opdima Digital Mammographic X-Ray SystemSiemens Medical Solutions USA, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003945	Opdima	Siemens Medical Solutions USA, Inc.	2001	—
0 (this device)	K071015	Opdima Digital Mammographic X-Ray System	Siemens Medical Solutions USA, Inc.	2007	—
+1	K072392	Opdima Digital Mammographic X-Ray System	Siemens Medical Solutions USA, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K071015, 2001–2007Source: 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 IZL? 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 IZL device

#1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 generations · no Class I recall
#2 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
*	K003945	Opdima Summary page 1 …earance Date Comparable Properties OPDIMA Digital * Hardware Mammographic X-ray K003945 02/02/2001 * Control Software system…	Siemens Medical Solutions USA, Inc.	2001	—

Also cleared against K003945: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072392	Opdima Digital Mammographic X-Ray System	Siemens Medical Solutions USA, Inc.	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?

Its one ancestor has no recall.
Of its descendants, K072392 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K003945.

How does its category compare?

All IZL devices

IZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IZL

11in 2025

2007high 16 (2022) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZL

153in 2025

2007high 159 (2024) · low 30 (2007)2026

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

Recalls per year · IZL

47in 2025

2007high 47 (2025) · low 0 (2008)2026

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

Adverse event reports per year · IZL

27in 2025

2007high 118 (2011) · low 16 (2007)2025

MAUDE reports naming product code IZL, 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	3	30	7	16
2008	4	49	0	27
2009	3	125	0	35
2010	3	65	4	75
2011	6	66	6	118
2012	3	83	5	24
2013	0	—	10	17
2014	7	104	4	51
2015	4	88	4	30
2016	6	47	0	33
2017	7	45	0	35
2018	8	47	0	27
2019	9	33	2	40
2020	9	43	1	48
2021	13	48	0	47
2022	16	89	1	32
2023	3	55	6	77
2024	9	159	5	39
2025	11	153	47	27
2026	6	157	5	—

What is it indicated for?

The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging. Such small field imaging is used during stereo tactic biopsy and diagnostic spot localization.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071015 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071015: Opdima Digital Mammographic X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071015

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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