510(k) · Cleared
ClearedClear Guide SCENERGY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clear Guide Medical · JAK System, X-Ray, Tomography, Computed
Cleared on Jan 17, 2024 as substantially equivalent to K201188 (Clear Guide Medical, 2020) after a 28-day review. Its family tree reaches back 10 generations to 1994. 6 of the 55 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 17, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K911783 (1994). 54 ancestors in all, the oldest K882383 (1988). No later device cites it as a predicate yet. 6 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 6 generations between
- 3 generations backK153004 Clear Guide SCENERGYClear Guide Medical · 2016
- 2 generations backK171677 Clear Guide SCENERGYClear Guide Medical · 2017
- 1 generation backK201188 Clear Guide SCENERGYClear Guide Medical · 2020
- This deviceK234030 Clear Guide SCENERGYClear Guide Medical · 2024
Show all 10 generations
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 9 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 8 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 7 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 6 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 5 generations backK121498 PercunavPhilips Health Care · 2012
- 4 generations backK132087 Percunav SystemPhilips Health Care · 2013
- 3 generations backK153004 Clear Guide SCENERGYClear Guide Medical · 2016
- 2 generations backK171677 Clear Guide SCENERGYClear Guide Medical · 2017
- 1 generation backK201188 Clear Guide SCENERGYClear Guide Medical · 2020
- This deviceK234030 Clear Guide SCENERGYClear Guide Medical · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −9 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −8 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −7 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −6 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −5 | K121498 | Percunav | Philips Health Care | 2012 | — |
| −4 | K132087 | Percunav System | Philips Health Care | 2013 | — |
| −3 | K153004 | Clear Guide SCENERGY | Clear Guide Medical | 2016 | — |
| −2 | K171677 | Clear Guide SCENERGY | Clear Guide Medical | 2017 | — |
| −1 | K201188 | Clear Guide SCENERGY | Clear Guide Medical | 2020 | — |
| 0 (this device) | K234030 | Clear Guide SCENERGY | Clear Guide Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 1 |
| 1997 | 2 | 0 |
| 1998 | 7 | 1 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 1 |
| 2005 | 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.
6 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 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? (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 |
|---|---|---|---|
| * | K201188 | Clear Guide SCENERGYSummary page 4…Class II under 21 CFR 892.1570 Predicate Device Information Device Name Clear Guide SCENERGY (Clear Guide Medical, Inc.) 510(k) Number K201188 Common Name System, Imaging Software Classification(s) JAK Computed tomography x-ray system… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 7 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 7 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 7 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 19 of the 54 ancestors have a recall of any class; 6 have 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. 2024, 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 Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR. The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation.…
Read the full statement (146 words)
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.
The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234030: Clear Guide SCENERGY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234030
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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