510(k) · Cleared
ClearedOptima XR646
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hualun Medical Systems Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Feb 18, 2015 as substantially equivalent to K132261 (Ge Medical Systems, LLC, 2013) and 1 other predicate after a 97-day review. Its family tree reaches back 6 generations to 1986. 6 later devices descend from it.
- Decided
- Feb 18, 2015
- Review
- 97 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K862120 (1986). 10 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 5 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 4 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 3 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK042602 Revolution XR/D Digital Radiographic Imaging System with Manual…Ge Medical Systems, LLC · 2005
- 1 generation backK050704 Modification to: Revolution XR/D Digital Radiographic Imaging System…General Electric Co. · 2005 · Recalled
- This deviceK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK231892 Definium Pace SelectGe Hualun Medical Systems Co., Ltd. · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK191699 Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK250788 Definium Tempo SelectGe Hualun Medical Systems Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK242678 Definium Pace Select ETGe Hualun Medical Systems Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · cites it directly5descendants
- K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd. · 2023 · 2 generations on1descendant
- K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd. · 2019 · 2 generations on1descendant
- K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd. · 2025 · 3 generations on0descendants
- K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −5 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −4 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −3 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −2 | K042602 | Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting | Ge Medical Systems, LLC | 2005 | — |
| −1 | K050704 | Modification to: Revolution XR/D Digital Radiographic Imaging System with… | General Electric Co. | 2005 | 2 |
| 0 (this device) | K143270 | Optima XR646 | Ge Hualun Medical Systems Co., Ltd. | 2015 | — |
| +1 | K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | 1 |
| +2 | K231892 | Definium Pace Select | Ge Hualun Medical Systems Co., Ltd. | 2023 | 1 |
| +2 | K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co., Ltd. | 2019 | 3 |
| +3 | K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co., Ltd. | 2025 | — |
| +3 | K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis)Summary page 4…92.1680) Product Code: KPR, MQB Predicate Device(s): Stationary X-Ray System, MODEL: Discovery XR656 (K132261) and Revolution XR/d with Image Pasting (K050704) Device Description: The Optima XR646 remains a… | 2013 |
| * | K050704 | Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting…Summary page 4…redicate Device(s): Stationary X-Ray System, MODEL: Discovery XR656 (K132261) and Revolution XR/d with Image Pasting (K050704) Device Description: The Optima XR646 remains a radiographic X-ray system capable of generating ra… | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172869 | Discovery XR656 HD | 2017 | 5 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K172869 (Ge Hualun Medical Systems Co., Ltd., 2017) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K132261.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Optima XR646 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams.
The device is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143270: Optima XR646.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143270
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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