510(k) · Cleared
Recalled · Class II · 2024Artemis Hand Held Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical Imaging · OWN Confocal Optical Imaging
Cleared on Jun 30, 2015 as substantially equivalent to K110480 (Hamamatsu Photonics K.K., 2012) and 1 other predicate after a 207-day review. Its family tree reaches back 7 generations to 1994. It has been recalled once.
- Decided
- Jun 30, 2015
- Review
- 207 days
- Class
- Class II
- Product code
- OWN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K944261 (1994). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 6 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 5 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 4 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 3 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK073130 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- 1 generation backK110480 Pde Photodynamic EyeHamamatsu Photonics K.K. · 2012
- This deviceK143474 Artemis Hand Held Imaging SystemQuest Medical Imaging · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −6 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −5 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −4 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −3 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K073130 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| −1 | K110480 | Pde Photodynamic Eye | Hamamatsu Photonics K.K. | 2012 | — |
| 0 (this device) | K143474 | Artemis Hand Held Imaging System | Quest Medical Imaging | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2014 | 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 OWN? 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 OWN device
- #1 K231854 1788 4K Camera System with Advanced Imaging…score 24.9 · 24 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 |
|---|---|---|---|
| * | K110480 | Pde Photodynamic EyeSummary page 4…1500 Product Code: OWN, GCJ Identification of Predicate Device(s): 510(k) Device Manufacturer Number K110480 PDE Hamamatsu Photonics K.K.… | 2012 |
| * | K132475 | Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control SystemSummary page 4…Number K110480 PDE Hamamatsu Photonics K.K. Hamamatsu City, Japan K132475 Fluobeam 800 Clinic Imaging Fluoptics, Grenoble Cedex, Device… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2024 | Class II | Z-0232-2025 | Component design/selection | Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K110480.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWN
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWN
197in 2025
MAUDE reports naming product code OWN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 87 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 208 | 0 | 0 |
| 2015 | 5 | 163 | 0 | 1 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 5 | 87 | 0 | 12 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 7 | 81 | 0 | 59 |
| 2020 | 7 | 81 | 0 | 105 |
| 2021 | 4 | 104 | 0 | 312 |
| 2022 | 4 | 41 | 3 | 346 |
| 2023 | 6 | 69 | 0 | 164 |
| 2024 | 1 | — | 1 | 165 |
| 2025 | 3 | 196 | 0 | 197 |
| 2026 | 7 | 63 | 0 | — |
What is it indicated for?
The Artemis Handheld Imaging System is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries.
The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143474: Artemis Hand Held Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143474
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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