510(k) · Cleared
ClearedPDX-2000 Portable Digital X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trex Enterprises Corp. · IZL System, X-Ray, Mobile
Cleared on Aug 16, 2001 as substantially equivalent to K973712 (Minxray, Inc., 1997) and 2 other predicates after a 21-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Aug 16, 2001
- Review
- 21 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945707 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1995 | — |
| −1 | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray Unit | Minxray, Inc. | 1997 | — |
| 0 (this device) | K012379 | PDX-2000 Portable Digital X-Ray System | Trex Enterprises Corp. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K973712 | Minxray HF100H High Frequency Diagnostic X-Ray UnitSummary page 1…(per 21 CFR section 892.1720) S0 IZL MinXray HF100H Portable X-ray Generator Manufactured by MinXray Inc. 3611 Commercial Avenue Northbrook, IL 60062-1822 80 1ZL - K973712 Decision Date: 12-12-97 Canon CXDI-11 X-ray Digital Camera & Canon CXDI-22 X-ray Digital Camera Manufactured by Canon U.S.A. I… | 1997 |
| * | K981556 | Canon X-Ray Digital Camera Cxdi-11Summary page 1…12-12-97 Canon CXDI-11 X-ray Digital Camera & Canon CXDI-22 X-ray Digital Camera Manufactured by Canon U.S.A. Inc. One Canon Plaza Lake Success, NY 11042 90 MQB - K 981556 & K992547 Decision Date: 10-13-89 The PDX-2000 Portable Digital X-ray System consists of a Canon X-ray digital camera CXDI-22 re… | 1998 |
| * | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22Summary page 1…Canon CXDI-11 X-ray Digital Camera & Canon CXDI-22 X-ray Digital Camera Manufactured by Canon U.S.A. Inc. One Canon Plaza Lake Success, NY 11042 90 MQB - K 981556 & K992547 Decision Date: 10-13-89 The PDX-2000 Portable Digital X-ray System consists of a Canon X-ray digital camera CXDI-22 retrofit kit… | 1999 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K973712.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PDX-2000 Portable Digital X-Ray System provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
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/K012379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012379: PDX-2000 Portable Digital X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012379
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026