510(k) · Cleared
ClearedZiehm Quantum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziehm Imaging, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on May 26, 2005 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 26, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK051064 Ziehm QuantumZiehm Imaging, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK190497 Ziehm 8000Ziehm Imaging GmbH · 2019
Most influential descendants
Showing 1 of 1 · See all- K190497Ziehm 8000Ziehm Imaging GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051064 | Ziehm Quantum | Ziehm Imaging, Inc. | 2005 | — |
| +1 | K190497 | Ziehm 8000 | Ziehm Imaging GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190497 | Ziehm 8000 | 2019 | 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?
- Of its descendants, K190497 (Ziehm Imaging GmbH, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic exams, including a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These include Cerebral, Thoracic, Vascular surgery; Abdominal, Orthopaedic, Peripheral, special Vascular-Flow Procedures, Dilatation, Em6lization, Stent Placement, Urological Procedures as well as Neuro-Vascular…
Read the full statement (101 words)
The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic exams, including a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These include Cerebral, Thoracic, Vascular surgery; Abdominal, Orthopaedic, Peripheral, special Vascular-Flow Procedures, Dilatation, Em6lization, Stent Placement, Urological Procedures as well as Neuro-Vascular, and other related fluoroscopic examinations requiring interventional procedures.
The ZIEHM QUANTUM Mobile C-arms are-also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051064: Ziehm Quantum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051064
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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