510(k) · Cleared
ClearedPrestodr Portable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmt Medical Technologies, Ltd. · IZL System, X-Ray, Mobile
Cleared on Apr 22, 2010 as substantially equivalent to K003438 (Cmt Medical Technologies, Ltd., 2001) and 1 other predicate after a 65-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Apr 22, 2010
- Review
- 65 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931071 (1994). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 2 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 1 generation backK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- This deviceK100400 Prestodr PortableCmt Medical Technologies, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK110849 Prestodr 4143Cmt Medical Technologies, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK162224 ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK131314 Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −2 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −1 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| 0 (this device) | K100400 | Prestodr Portable | Cmt Medical Technologies, Ltd. | 2010 | — |
| +1 | K110849 | Prestodr 4143 | Cmt Medical Technologies, Ltd. | 2011 | — |
| +2 | K162224 | ArtPix Mobile EZ2GO | Cmt Medical Technologies, Ltd. | 2016 | — |
| +1 | K131314 | Ddrcruze (Digital Mobile Diagnostic X-Ray System) | Swissray Medical AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K003438 | Smart RadSummary page 1…ified flucroscopic x-ray system Regulatory class: Class 11 Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed Equivalent Devices K003438 SMARTRAD K090625 WIRELESS PORTABLE DETECTOR FD-W17 ‘ Device Description. - Co The PrestoDR Portable is a Digital Radiography sy… | 2001 |
| * | K090625 | Wireless Portable Detector FD-W17Summary page 1…x-ray system Regulatory class: Class 11 Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed Equivalent Devices K003438 SMARTRAD K090625 WIRELESS PORTABLE DETECTOR FD-W17 ‘ Device Description. - Co The PrestoDR Portable is a Digital Radiography system, featuring an… | 2009 |
What descends from it? (3)
2 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 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K110849 (Cmt Medical Technologies, Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K003438.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
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/K100400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100400: Prestodr Portable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100400
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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