510(k) · Cleared
Recalled · Class II · 2025Optima XR646 HD
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 Dec 11, 2017 as substantially equivalent to K172869 (Ge Hualun Medical Systems Co., Ltd., 2017) after a 19-day review. Its family tree reaches back 8 generations to 1986. It has been recalled once.
- Decided
- Dec 11, 2017
- Review
- 19 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K862120 (1986). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 7 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 6 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 5 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK042602 Revolution XR/D Digital Radiographic Imaging System with Manual…Ge Medical Systems, LLC · 2005
- 3 generations backK050704 Modification to: Revolution XR/D Digital Radiographic Imaging System…General Electric Co. · 2005 · Recalled
- 2 generations backK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- 1 generation backK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
- This deviceK173612 Optima XR646 HDGe Hualun Medical Systems Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −7 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −6 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −5 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −4 | K042602 | Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting | Ge Medical Systems, LLC | 2005 | — |
| −3 | K050704 | Modification to: Revolution XR/D Digital Radiographic Imaging System with… | General Electric Co. | 2005 | 2 |
| −2 | K143270 | Optima XR646 | Ge Hualun Medical Systems Co., Ltd. | 2015 | — |
| −1 | K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | 1 |
| 0 (this device) | K173612 | Optima XR646 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | — |
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 |
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? (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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2025 | Class II | Z-1046-2025 | Radiation Control for Health and Safety Act | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K172869.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 HD 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 the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
The device is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173612: Optima XR646 HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173612
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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