510(k) · Cleared
Recalled · Class II · 2016Brivo XR385
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · KPR System, X-Ray, Stationary
Cleared on Aug 12, 2011 as substantially equivalent to K982955 (GE Medical Systems, 1998) and 2 other predicates after a 261-day review. Its family tree reaches back 4 generations to 1998. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 12, 2011
- Review
- 261 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K981556 (1998). 9 ancestors in all, the oldest K862120 (1986). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 3 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 2 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 1 generation backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- This deviceK103448 Brivo XR385Ge Medical Systems, LLC · 2011
- Descendant · cites it directly · 3 of its ownK141381 DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK163410 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK201725 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK201640 DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K141381DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · cites it directly3descendants
- K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · 2 generations on1descendant
- K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · 3 generations on0descendants
- K201640DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −3 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −2 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −1 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| 0 (this device) | K103448 | Brivo XR385 | Ge Medical Systems, LLC | 2011 | — |
| +1 | K141381 | Duradiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2014 | 7 |
| +2 | K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017 | 4 |
| +3 | K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | 2020 | 3 |
| +2 | K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 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? (3)
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 |
|---|---|---|---|
| * | K982955 | Silhouette VRSummary page 2…ray imager (2ICFR § 892.1650) Product Code: KPR and MQB Predicate Device(s): Stationary x-ray system MODEL: Silhouette VR (K982955) GE Tethered Portable Digital Radiographic Detector (K041922) Canon d… | 1998 |
| * | K041922 | GE Tethered Portable Digital Radiographic DetectorSummary page 2…B Predicate Device(s): Stationary x-ray system MODEL: Silhouette VR (K982955) GE Tethered Portable Digital Radiographic Detector (K041922) Canon digital radiography CXDI-50G (K03 1447) Device Description: The Brivo XR385 Digita… | 2004 |
| * | K031447 | Canon, Digital Radiography, Model Cxdi-50GSummary page 2…VR (K982955) GE Tethered Portable Digital Radiographic Detector (K041922) Canon digital radiography CXDI-50G (K03 1447) Device Description: The Brivo XR385 Digital Diagnostic Radiographic system provides stat… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141381 | Duradiagnost | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2016 | Class II | Z-2523-2018 | Component change control | The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K141381 (Philips Healthcare (Suzhou) Co., Ltd., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Brivo XR385 Digital X-Ray System is intended for use on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patent sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103448: Brivo XR385.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103448
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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