510(k) · Cleared
Recalled · Class II · 2024Ziehm Vision 2
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 Mar 21, 2008 as substantially equivalent to K011292 (Ziehm International, Inc., 2001) and 2 other predicates after a 113-day review. Its family tree reaches back 3 generations to 2000. 1 of the 36 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 21, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003266 (2000). 7 ancestors in all. 28 later devices descend from it, 4 citing it directly. 1 of the 36 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 2 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 1 generation backK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- This deviceK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008
- Descendant · cites it directly · 17 of its ownK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 16 of its ownK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled
- Descendant · cites it directly · 10 of its ownK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- Descendant · cites it directly · 9 of its ownK092438 Ziehm SoloZiehm Imaging, Inc. · 2009 · Recalled
- Descendant · cites it directly · 8 of its ownK161976 Ziehm Solo FDZiehm Imaging GmbH · 2016 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System3 generations back · 2001
Most influential descendants
Showing 5 of 28 · See all- K083545Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · cites it directly17descendants
- K132904Ziehm Vision RFDZiehm Imaging GmbH · 2013 · 2 generations on16descendants
- K142740Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · cites it directly10descendants
- K092438Ziehm SoloZiehm Imaging, Inc. · 2009 · cites it directly9descendants
- K161976Ziehm Solo FDZiehm Imaging GmbH · 2016 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −2 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −1 | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| 0 (this device) | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | — |
| +1 | K083545 | Ziehm Vision RFD | Ziehm Imaging, Inc. | 2009 | 3 |
| +2 | K132904 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2013 | 1 |
| +1 | K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2015 | 1 |
| +1 | K092438 | Ziehm Solo | Ziehm Imaging, Inc. | 2009 | 4 |
| +1 | K161976 | Ziehm Solo FD | Ziehm Imaging GmbH | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 1 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K011292 | Ziehm VisionSummary page 2…m .2 510(k) Summary Zichm Imaging, Inc. Ziehm Yision * existing Ziehm Vision C-arm devices, which are legally marketed devices (Ziehm Vision application K011292, Ziehm Vision FD application K 061534, and Ziehm Vario 3D application K061310). Substantial Equivalence: The ZIEHM VISION2 prod… | 2001 |
| * | K061534 | Ziehm Vision FD Digital Mobile Imaging SystemSummary page 2…ichm Imaging, Inc. Ziehm Yision * existing Ziehm Vision C-arm devices, which are legally marketed devices (Ziehm Vision application K011292, Ziehm Vision FD application K 061534, and Ziehm Vario 3D application K061310). Substantial Equivalence: The ZIEHM VISION2 product family of mobile c-arm products do… | 2006 |
| * | K061310 | Ziehm Vario 3D Digital Mobile Imaging SystemSummary page 2…ng Ziehm Vision C-arm devices, which are legally marketed devices (Ziehm Vision application K011292, Ziehm Vision FD application K 061534, and Ziehm Vario 3D application K061310). Substantial Equivalence: The ZIEHM VISION2 product family of mobile c-arm products does not raise new questions of safety or… | 2006 |
What descends from it? (28)
See all 284 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2024 | Class II | Z-0575-2025 | Radiation Control for Health and Safety Act | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when… |
| Apr 15, 2016 | Class II | Z-2644-2016 | Device Design | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. |
| Nov 21, 2013 | Class II | Z-0564-2014 | Device Design | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. |
| Nov 21, 2013 | Class II | Z-0565-2014 | Device Design | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. |
| Apr 29, 2011 | Not classified | Z-1430-2012 | Component design/selection | On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic… |
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 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K083545 (Ziehm Imaging, Inc., 2009) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K011292.
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. 2008, this device’s year, is highlighted.
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 VISION’ product Family is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures. Radiographic film examinations can be made with an…
Read the full statement (393 words)
The ZIEHM VISION’ product Family is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.
ZIEHM VISION with option VARIO is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures. and whenever the clinician benefits from variable Iso-centric positioning. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.
ZIEHM VISION® with option FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and where higher accuracy in image geometry is required in and around high magnetic fields. At the discretion of a physician the device may be used for other imaging applications.
ZIEHM VISION® with option 3D is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurological, critical care, and emergency room procedures and Whenever the clinician benefits from variable 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, and where digital image and c-arm positioning data is required for computer aided surgery procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. At the discretion of a physician the device may be used for other imaging applications.
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/K073346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073346: Ziehm Vision 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073346
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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