510(k) · Cleared
ClearedParagon 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Medical Systems, LLC · IZL System, X-Ray, Mobile
Cleared on Oct 21, 2016 as substantially equivalent to K161345 (Sedecal., Sa., 2016) after a 24-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Oct 21, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K896095 (1990). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 2 generations backK101517 Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · Recalled
- 1 generation backK161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model…Sedecal., Sa. · 2016 · Recalled
- This deviceK162687 Paragon 2Meridian Medical Systems, LLC · 2016
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 4 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 3 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 2 generations backK101517 Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · Recalled
- 1 generation backK161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model…Sedecal., Sa. · 2016 · Recalled
- This deviceK162687 Paragon 2Meridian Medical Systems, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −5 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −4 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −3 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −2 | K101517 | Sedecal Mobile Digital Diagnostic X-Ray | Sedecal., Sa. | 2011 | 4 |
| −1 | K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Sedecal., Sa. | 2016 | 13 |
| 0 (this device) | K162687 | Paragon 2 | Meridian Medical Systems, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSummary page 4…le X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System 2. Equivalent legally marketed device: K161345 Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR. Manufacturer: Sedecal SA (S… | 2016 |
| † | K143232 | Universal Digital Interface 2W, UDI 2W | 2015 |
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 26 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 20 ancestors have a recall of any class.
- 4 other devices also cite its predicate K161345.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
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/K162687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162687: Paragon 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162687
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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