510(k) · Cleared
Recalled · Class II · 2023SPiN Thoracic Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veran Medical Technologies, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on May 15, 2017 as substantially equivalent to K122106 (Veran Medical Technologies, Inc., 2012) and 1 other predicate after a 132-day review. Its family tree reaches back 12 generations to 1993. 1 of the 23 devices in its family, counting itself, has a Class I recall. It has been recalled 15 times.
- Decided
- May 15, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 15
- Predicates
- 2
Its longest line of descent runs back 12 generations to K926514 (1993). 22 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 8 generations between
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK091934 IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory…Veran Medical Technologies, Inc. · 2009
- 1 generation backK122106 Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip…Veran Medical Technologies, Inc. · 2012 · Recalled
- This deviceK170023 SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc. · 2017
Show all 12 generations
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 10 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 9 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 8 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 7 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 6 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 5 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 4 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK091934 IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory…Veran Medical Technologies, Inc. · 2009
- 1 generation backK122106 Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip…Veran Medical Technologies, Inc. · 2012 · Recalled
- This deviceK170023 SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc. · 2017
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…8 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −11 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −10 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −9 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −8 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −7 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −6 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −5 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −4 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −3 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K091934 | IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4… | Veran Medical Technologies, Inc. | 2009 | — |
| −1 | K122106 | Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked… | Veran Medical Technologies, Inc. | 2012 | 13 |
| 0 (this device) | K170023 | SPiN Thoracic Navigation System | Veran Medical Technologies, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2006 | 1 | 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 |
|---|---|---|---|
| * | K122106 | Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Summary page 4…ray System, Bronchoscope Accessory, Bronchoscope (Flexible or Rigid) 21 CFR 892.1750 JAK, LLZ Veran Medical Technologies, Inc. SPiN Drive CT stereotactic accessory K122106 Computed Tomography X-ray System 21 CFR 892.1750 JAK Veran Medical Technologies, Inc. inReach System Bronchoscope K081379… | 2012 |
| * | K081379 | Modification to Inreach SystemSummary page 4…. SPiN Drive CT stereotactic accessory K122106 Computed Tomography X-ray System 21 CFR 892.1750 JAK Veran Medical Technologies, Inc. inReach System Bronchoscope K081379 Computed Tomography X-ray System JAK superDimension, LTD 10 5+ '$#"%! " #"), # 0#!… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class II | Z-2663-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2660-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2661-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2659-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2662-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2664-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| May 15, 2023 | Class II | Z-2263-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2269-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2267-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2268-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2266-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2264-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2265-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2262-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| Dec 13, 2022 | Class II | Z-1103-2023 | Under Investigation by firm | A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional… |
The 5 latest of 15 recalls; the web page lists all.
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 8 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 10 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
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. 2017, 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 SPiN Thoracic Navigation System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The SPiN Thoracic Navigation System is indicated for displaying; + An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s). * Images of the tracheobronchial tree to aid a physician in guiding endoscopic…
Read the full statement (128 words)
The SPiN Thoracic Navigation System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The SPiN Thoracic Navigation System is indicated for displaying;
+ An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
* Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract,
The SPiN Thoracic Navigation System compensates for the patient's respiratory phases.
The SPiN Thoracic Navigation System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.
The SPiN Thoracic Navigation System enables marker placement in soft lung tissue.
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/K170023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170023: SPiN Thoracic Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170023
Report an extraction error
Are you the manufacturer?
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