510(k) · Cleared
ClearedArtPix Mobile EZ2GO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmt Medical Technologies, Ltd. · KPR System, X-Ray, Stationary
Cleared on Sep 22, 2016 as substantially equivalent to K110849 (Cmt Medical Technologies, Ltd., 2011) after a 45-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Sep 22, 2016
- Review
- 45 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931071 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 4 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 3 generations backK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- 2 generations backK100400 Prestodr PortableCmt Medical Technologies, Ltd. · 2010
- 1 generation backK110849 Prestodr 4143Cmt Medical Technologies, Ltd. · 2011
- This deviceK162224 ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −4 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −3 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| −2 | K100400 | Prestodr Portable | Cmt Medical Technologies, Ltd. | 2010 | — |
| −1 | K110849 | Prestodr 4143 | Cmt Medical Technologies, Ltd. | 2011 | — |
| 0 (this device) | K162224 | ArtPix Mobile EZ2GO | Cmt Medical Technologies, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K110849 | Prestodr 4143Summary page 4…/ digital imager) 1.4. Reason for 510K Submission Special 510K Submission 1.5. Identification of Legally Marketed equivalent Devices PrestoDR 4143 K110849 Classification Name: Stationary X-Ray System Classification Regulation: 21CFR 892.1680 Classification P… | 2011 |
| † | K141440 | Dicompacs DX-R with Flat Panel | 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)
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 22 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 8 ancestors have a recall of any class.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The ArtPix Mobile EZ2GO, is intended for use in general radiographic examinations by qualified/trained doctors or technicians, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography.
ArtPix Mobile EZ2GO allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position
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/K162224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162224: ArtPix Mobile EZ2GO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162224
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