510(k) · Cleared
ClearedMAXIO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perfint Healthcare Pvt, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on May 19, 2014 as substantially equivalent to K060903 (Veran Medical Technologies, Inc., 2006) and 1 other predicate after a 315-day review. Its family tree reaches back 2 generations to 2000. 27 later devices descend from it.
- Decided
- May 19, 2014
- Review
- 315 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001284 (2000). 4 ancestors in all, the oldest K974513 (1998). 27 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 1 generation backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- This deviceK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- Descendant · cites it directly · 16 of its ownK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- Descendant · 2 generations on · 11 of its ownK202297 Aline Ablation IntelligenceMirada Medical, Ltd. · 2020
- Descendant · 3 generations on · 4 of its ownK220256 MIM-AblationMim Software, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK191332 XACT Robotic SystemXact Robotics, Ltd. · 2019
- Descendant · 2 generations on · 3 of its ownK161285 Ablation ConfirmationNeuwave Medical, Inc. · 2016
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K150313Ablation ConfirmationNeuwave Medical, Inc. · 2015 · cites it directly16descendants
- K202297Aline Ablation IntelligenceMirada Medical, Ltd. · 2020 · 2 generations on11descendants
- K220256MIM-AblationMim Software, Inc. · 2022 · 3 generations on4descendants
- K191332XACT Robotic SystemXact Robotics, Ltd. · 2019 · cites it directly3descendants
- K161285Ablation ConfirmationNeuwave Medical, Inc. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −1 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| +1 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| +2 | K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020 | — |
| +3 | K220256 | MIM-Ablation | Mim Software, Inc. | 2022 | — |
| +1 | K191332 | XACT Robotic System | Xact Robotics, Ltd. | 2019 | — |
| +2 | K161285 | Ablation Confirmation | Neuwave Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
Planning a device in JAK? 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 |
|---|---|---|---|
| * | K060903 | IG4 Image Guided SystemSummary page 1…Product Code: JAK 4. Date prepared: May 14, 2014 5. Substantial equivalence claimed to: ig4 Image Guided System (K060903) Pinpoint (K9745 13) 6. Device Description MAXIOTM is an image-guided, physi… | 2006 |
| * | K974513 | PinpointSummary page 1…d: May 14, 2014 5. Substantial equivalence claimed to: ig4 Image Guided System (K060903) Pinpoint (K9745 13) 6. Device Description MAXIOTM is an image-guided, physician controlled stereotactic accessory to a Computed Tomo… | 1998 |
What descends from it? (27)
See all 275 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K150313 (Neuwave Medical, Inc., 2015) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K060903.
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. 2014, 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?
MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures. MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during…
Read the full statement (109 words)
MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement.
MAXIO™ is indicated for use with rigid straight instruments such as needles and probes used in Computed Tomography (CT) guided percutaneous interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132108 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132108: MAXIO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132108
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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