510(k) · Cleared
Recalled · Class II · 2025RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal., Sa. · IZL System, X-Ray, Mobile
Cleared on Jul 6, 2016 as substantially equivalent to K101517 (Sedecal., Sa., 2011) after a 54-day review. Its family tree reaches back 8 generations to 1990. 14 later devices descend from it. It has been recalled 13 times.
- Decided
- Jul 6, 2016
- Review
- 54 days
- Class
- Class II
- Product code
- IZL
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 19 ancestors in all. 14 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 2 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 1 generation backK101517 Sedecal Mobile Digital Diagnostic X-RaySedecal., Sa. · 2011 · Recalled
- This deviceK161345 RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model…Sedecal., Sa. · 2016
- Descendant · cites it directly · 8 of its ownK192011 PhoeniXSedecal., Sa. · 2019
- Descendant · 2 generations on · 4 of its ownK212291 PhoenixSedecal., Sa. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK222951 SM-VSedecal., Sa. · 2022
- Descendant · cites it directly · 1 of its ownK201340 Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda · 2020
- Descendant · cites it directly · 1 of its ownK181874 MX40 Mobile Digital X-ray SystemHuestis Machine Corporation · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K192011PhoeniXSedecal., Sa. · 2019 · cites it directly8descendants
- K212291PhoenixSedecal., Sa. · 2021 · 2 generations on4descendants
- K222951SM-VSedecal., Sa. · 2022 · 3 generations on1descendant
- K201340Aquila 320 D / Aquila 320 SVmi Tecnologias Ltda · 2020 · cites it directly1descendant
- K181874MX40 Mobile Digital X-ray SystemHuestis Machine Corporation · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −2 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −1 | K101517 | Sedecal Mobile Digital Diagnostic X-Ray | Sedecal., Sa. | 2011 | 4 |
| 0 (this device) | K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Sedecal., Sa. | 2016 | — |
| +1 | K192011 | PhoeniX | Sedecal., Sa. | 2019 | — |
| +2 | K212291 | Phoenix | Sedecal., Sa. | 2021 | 1 |
| +3 | K222951 | SM-V | Sedecal., Sa. | 2022 | — |
| +1 | K201340 | Aquila 320 D / Aquila 320 S | Vmi Tecnologias Ltda | 2020 | — |
| +1 | K181874 | MX40 Mobile Digital X-ray System | Huestis Machine Corporation | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K101517 | Sedecal Mobile Digital Diagnostic X-RaySummary 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: K101517 Trade/Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Regulation Number: 21CFR892.1720 Reg… | 2011 |
What descends from it? (14)
See all 145 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2025 | Class II | Z-0245-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0251-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0244-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0247-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0250-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0252-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0281-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0246-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0248-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0284-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0249-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jun 10, 2025 | Class II | Z-0285-2026 | Device Design | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper… |
| Jan 22, 2024 | Class II | Z-1754-2024 | Component design/selection | Potential interference with the anti-fall system. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 19 ancestors have a recall of any class.
- Of its descendants, K192011 (Sedecal., Sa., 2019) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K101517.
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 as stated in the FDA summary.
https://510kreport.com/device/K161345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161345: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161345
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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