510(k) · Cleared
ClearedArtemis, Artemis TPO, Artemis MX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eigen · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Cleared on Oct 12, 2023 as substantially equivalent to K162474 (Eigen, 2016) and 1 other predicate after a 444-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Oct 12, 2023
- Review
- 444 days
- Class
- Class II
- Product code
- QTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954678 (1996). 12 ancestors in all, the oldest K953259 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- 3 generations backK081093 3-D Imaging WorkstationEigen, LLC · 2008
- 2 generations backK153073 UroNav (Version 2.0)Invivo Corporation · 2015
- 1 generation backK162474 ArtemisEigen · 2016
- This deviceK222222 Artemis, Artemis TPO, Artemis MXEigen · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| −3 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| −2 | K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015 | — |
| −1 | K162474 | Artemis | Eigen | 2016 | — |
| 0 (this device) | K222222 | Artemis, Artemis TPO, Artemis MX | Eigen | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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.
Planning a device in QTZ? 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 QTZ device
- #1 K252947 HistoSonics® Planning Toolscore 14.4 · 11 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 |
|---|---|---|---|
| * | K162474 | ArtemisSummary page 4…redicate Devices: Device Name 510(k) Number Type Artemis K162474 Primary ICEfx Cryoablation System K181153 Reference The design, funct… | 2016 |
| * | K081093 | 3-D Imaging WorkstationSummary page 9…Primary Predicate Device: Eigen, LLC Reference Predicate Device: ICEfx Eigen 3-D Imaging Workstation K081093 Cryoablation System (K181153) Artemis Intended Use Artemis along with the Needle Guide Artemis alo… | 2008 |
| † | K181153 | ICEfx Cryoablation System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K162474.
How does its category compare?
All QTZ devicesQTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QTZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QTZ
351in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QTZ
No recall names QTZ since 2007.
Adverse event reports per year · QTZ
No MAUDE report names QTZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | 351 | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy…
Read the full statement (337 words)
Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management.
Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.
Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure.
The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder and urethra.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222222: Artemis, Artemis TPO, Artemis MX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222222
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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