510(k) · Cleared
ClearedZiehm Vario 3D Digital Mobile Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziehm Imaging, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jul 7, 2006 as substantially equivalent to K003266 (Siemens Medical Solutions USA, Inc., 2000) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 2000. 1 of the 34 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Jul 7, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003266 (2000). 4 ancestors in all. 29 later devices descend from it, 1 citing it directly. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 1 generation backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- This deviceK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- Descendant · cites it directly · 28 of its ownK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 17 of its ownK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 16 of its ownK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled
- Descendant · 2 generations on · 10 of its ownK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- Descendant · 2 generations on · 9 of its ownK092438 Ziehm SoloZiehm Imaging, Inc. · 2009 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System2 generations back · 2001
Most influential descendants
Showing 5 of 29 · See all- K073346Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · cites it directly28descendants
- K083545Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · 2 generations on17descendants
- K132904Ziehm Vision RFDZiehm Imaging GmbH · 2013 · 3 generations on16descendants
- K142740Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · 2 generations on10descendants
- K092438Ziehm SoloZiehm Imaging, Inc. · 2009 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −1 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| 0 (this device) | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| +1 | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | 5 |
| +2 | K083545 | Ziehm Vision RFD | Ziehm Imaging, Inc. | 2009 | 3 |
| +3 | K132904 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2013 | 1 |
| +2 | K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2015 | 1 |
| +2 | K092438 | Ziehm Solo | Ziehm Imaging, Inc. | 2009 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 0 |
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.
1 device in this family has a Class I recall. 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K003266 | Siremobil Iso-C 3DSummary page 1…3D)is substantially equivalent to the following devices that are currently marketed: - SIEMENS Medical Systems AG ISO-C 3D Mobile Surgical C-arm System 510(k) K003266 - SIEMENS Medical Solufions USA, ISO-C 3D Mobile C-arm System 5l0(k) K032280 'These devices are mobile C-aim x-ray sy… | 2000 |
| * | K032280 | Siremobil Iso-C 3DSummary page 1…ed: - SIEMENS Medical Systems AG ISO-C 3D Mobile Surgical C-arm System 510(k) K003266 - SIEMENS Medical Solufions USA, ISO-C 3D Mobile C-arm System 5l0(k) K032280 'These devices are mobile C-aim x-ray systems intended for fluoroscopic and 3d imaging. The systems include high-voltage x… | 2003 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073346 | Ziehm Vision 2 | 2008 | 28 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K073346 (Ziehm Imaging, Inc., 2008) has gone furthest, with 28 descendants of its own.
- 6 other devices also cite its predicate K003266.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the…
Read the full statement (122 words)
The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician the device may be used for other imaging applications.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061310 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061310: Ziehm Vario 3D Digital Mobile Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061310
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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