510(k) · Cleared
ClearedDigital Radiographic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · KPR System, X-Ray, Stationary
Cleared on Oct 6, 1998 as substantially equivalent to K862120 (General Electric Co., 1986) after a 106-day review. Its family tree reaches back 1 generation to 1986. 221 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 106 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862120 (1986). 221 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- This deviceK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- Descendant · cites it directly · 104 of its ownK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- Descendant · 2 generations on · 103 of its ownK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- Descendant · cites it directly · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · 2 generations on · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- Descendant · 3 generations on · 48 of its ownK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
Showing 5 of 221 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 221 · See all- K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999 · cites it directly104descendants
- K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · 2 generations on103descendants
- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · cites it directly103descendants
- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · 2 generations on78descendants
- K123098Xgeo GC80Samsung Electronics Co., Ltd. · 2013 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| 0 (this device) | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| +1 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| +2 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| +1 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| +3 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 10 | 0 |
| 2013 | 10 | 0 |
| 2014 | 17 | 0 |
| 2015 | 14 | 0 |
| 2016 | 18 | 0 |
| 2017 | 15 | 0 |
| 2018 | 18 | 0 |
| 2019 | 14 | 0 |
| 2020 | 9 | 0 |
| 2021 | 12 | 0 |
| 2022 | 16 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K862120 | SCX SystemSummary page 1…em GE Medical Systems 3000 N. Grandview Bivd. Waukesha, Wl 53188 The SG60 vertical wallstand was pre-Amendment and the SCX radiographic system was introduced in 1986 (K862120). Subsequently, these were used with the Ultranet-SA Collimator (K894142), the Maxiray 100 Radiographic Tube (K812915), and the S… | 1986 |
| * | — | SG-60 vertical wallstand Named without a submission number |
What descends from it? (221)
See all 2214 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?
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The Digital Radiographic Imaging System 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 mammographic applications.
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/K982196 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982196: Digital Radiographic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982196
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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