510(k) · Cleared
ClearedSkanmobile, Skanmobile-Dr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skanray Technologies Limited · IZL System, X-Ray, Mobile
Cleared on Mar 4, 2022 as substantially equivalent to K182317 (Oehm Und Rehbein GmbH, 2018) and 1 other predicate after a 170-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Mar 4, 2022
- Review
- 170 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K981556 (1998). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 6 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 5 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 4 generations backK042361 Digital Portable X-Ray Units, Model SP-HF-4.0 DSedecal USA, Inc. · 2004
- 3 generations backK121410 Dragon LWSedecal., Sa. · 2012
- 2 generations backK173299 Dragon X SPSL4HC, Dragon X SPSL8HCSedecal., Sa. · 2018
- 1 generation backK182317 AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH · 2018
- This deviceK212940 Skanmobile, Skanmobile-DrSkanray Technologies Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −7 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −6 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −5 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −4 | K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 D | Sedecal USA, Inc. | 2004 | — |
| −3 | K121410 | Dragon LW | Sedecal., Sa. | 2012 | — |
| −2 | K173299 | Dragon X SPSL4HC, Dragon X SPSL8HC | Sedecal., Sa. | 2018 | — |
| −1 | K182317 | AMADEO M-DR mini, AMADEO M-AX mini | Oehm Und Rehbein GmbH | 2018 | — |
| 0 (this device) | K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K182317 | AMADEO M-DR mini, AMADEO M-AX miniSummary page 5…Device Class: Class II Product Code: IZL MQB Predicate Device(s): • AMADEO M-DR mini, AMADEO M-AX mini (K182317) Regulation number: 892.1720 Regulation name: Mobile X-Ray system… | 2018 |
| * | K173299 | Dragon X SPSL4HC, Dragon X SPSL8HCSummary page 6…Section 5: Page 1 of 19 • DRAGON X SPSL4HC; DRAGON X SPSL8HC (K173299) Regulation number: 892.1720 Regulation name: Mobile X-Ray system… | 2018 |
| † | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | 2016 |
| † | K162178 | CareView 1500P X-ray Flat Panel Detectors | 2016 |
| † | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | 2016 |
| † | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | 2015 |
| † | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | 2013 |
| † | K030487 | R 72 | 2003 |
| † | K193644 | E-Com DR-2000 DR | 2020 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K182317.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals. SKANMOBILE and SKANMOBILE-DR are indicated for taking…
Read the full statement (117 words)
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212940: Skanmobile, Skanmobile-Dr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212940
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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