510(k) · Cleared
ClearednView s1 with nav option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nview Medical · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 28, 2022 as substantially equivalent to K211064 (Nview Medical, 2021) after a 233-day review. Its family tree reaches back 9 generations to 2000. 3 of the 17 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 28, 2022
- Review
- 233 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003266 (2000). 16 ancestors in all. No later device cites it as a predicate yet. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 5 generations between
- 3 generations backK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- 2 generations backK190064 nView system 1Nview Medical, Inc. · 2019
- 1 generation backK211064 nView s1 with nav optionNview Medical · 2021
- This deviceK221344 nView s1 with nav optionNview Medical · 2022
Show all 9 generations
- Root · 9 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 8 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 7 generations backK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- 6 generations backK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
- 5 generations backK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
- 4 generations backK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled
- 3 generations backK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- 2 generations backK190064 nView system 1Nview Medical, Inc. · 2019
- 1 generation backK211064 nView s1 with nav optionNview Medical · 2021
- This deviceK221344 nView s1 with nav optionNview Medical · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −8 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −7 | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| −6 | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | 5 |
| −5 | K083545 | Ziehm Vision RFD | Ziehm Imaging, Inc. | 2009 | 3 |
| −4 | K132904 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2013 | 1 |
| −3 | K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2015 | 1 |
| −2 | K190064 | nView system 1 | Nview Medical, Inc. | 2019 | — |
| −1 | K211064 | nView s1 with nav option | Nview Medical | 2021 | — |
| 0 (this device) | K221344 | nView s1 with nav option | Nview Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 1 |
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
| 2006 | 2 | 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.
3 devices in this family have 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 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? (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 | Decided |
|---|---|---|---|
| * | K211064 | nView s1 with nav optionSummary page 4…roduct Code: OWB Secondary Product Codes: OXO, JAA, JAK, OLO Predicate Device Information Device Name (510(k) number): nView s1 with nav option (K211064) Common/Usual Name: Mobile Fluoroscopic C-Arm Regulation Number: CFR 892.1650 Regulation Name:… | 2021 |
| † | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 7 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 16 ancestors have a recall of any class; 3 have a Class I recall.
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. 2022, this device’s year, is highlighted.
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 nView sl is intended as an imaging system to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint…
Read the full statement (211 words)
The nView sl is intended as an imaging system to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The nView sl is indicated to image human anatomy up to 30 cm thickness.
The nView sl is not indicated for mammographic or lung nodule applications.
The nView sl with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediatric populations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView sl images of the anatomy.
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/K221344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221344: nView s1 with nav option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221344
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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