510(k) · Cleared
ClearedGE Tethered Portable Digital Radiographic Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IZL System, X-Ray, Mobile
Cleared on Jul 28, 2004 as substantially equivalent to K982196 (GE Medical Systems, 1998) after a 12-day review. Its family tree reaches back 2 generations to 1986. 20 later devices descend from it.
- Decided
- Jul 28, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862120 (1986). 20 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 1 generation backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- This deviceK041922 GE Tethered Portable Digital Radiographic DetectorGeneral Electric Co. · 2004
- Descendant · cites it directly · 14 of its ownK063283 Definium 5000 X-Ray SystemSedecal., Sa. · 2006 · Recalled
- Descendant · 2 generations on · 13 of its ownK122495 Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc. · 2012
- Descendant · 3 generations on · 12 of its ownK140551 Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 2014
- Descendant · 4 generations on · 7 of its ownK142698 PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc. · 2014
- Descendant · 4 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K063283Definium 5000 X-Ray SystemSedecal., Sa. · 2006 · cites it directly14descendants
- K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc. · 2012 · 2 generations on13descendants
- K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 2014 · 3 generations on12descendants
- K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc. · 2014 · 4 generations on7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −1 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| 0 (this device) | K041922 | GE Tethered Portable Digital Radiographic Detector | General Electric Co. | 2004 | — |
| +1 | K063283 | Definium 5000 X-Ray System | Sedecal., Sa. | 2006 | 3 |
| +2 | K122495 | Perkinelmer XRD 1622 AP3 Med Flat Panel Detector | Perkinelmer, Inc. | 2012 | — |
| +3 | K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel Detector | Perkinelmer, Inc. | 2014 | — |
| +4 | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | Perkinelmer, Inc. | 2014 | — |
| +4 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K982196 | Digital Radiographic Imaging SystemSummary page 1…e Digital Radiographic Detector. Mobile X-ray System, 21 CFR 892.1720, 90 IZL Marketed Device: GE Digital Radiographic Imaging System, 510(k) Number K982196, currently in commercial distribution. Device Description: The GE Tethered Portable Digital Radiographic Detec… | 1998 |
What descends from it? (20)
See all 202 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 18 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K063283 (Sedecal., Sa., 2006) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K982196.
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 GE Tethered Portable Digital Radiographic Detector is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammograpohic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041922: GE Tethered Portable Digital Radiographic Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041922
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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