510(k) · Cleared
ClearedX-ray Flat Panel Detectors/CareView 3600RF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careray Digital Medical System Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Feb 19, 2021 as substantially equivalent to K161730 (Iray Technology (Shanghai), Ltd., 2016) after a 141-day review. Its family tree reaches back 11 generations to 1998.
- Decided
- Feb 19, 2021
- Review
- 141 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K981556 (1998). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations between
- 3 generations backK123644 Vizion + DRViztek, LLC · 2013
- 2 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 1 generation backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- This deviceK202995 X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 9 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 8 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 7 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 6 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 5 generations backK102123 Vizion DRViztek, Inc. · 2011
- 4 generations backK112661 Vizion DRViztek, LLC · 2011
- 3 generations backK123644 Vizion + DRViztek, LLC · 2013
- 2 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 1 generation backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- This deviceK202995 X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −10 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −9 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −8 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −7 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −6 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −5 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −4 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −3 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| −2 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| −1 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| 0 (this device) | K202995 | X-ray Flat Panel Detectors/CareView 3600RF | Careray Digital Medical System Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K161730 | Wireless Digital Flat Panel DetectorSummary page 6…Page 2 of 7 Regulatory Class: Class II Product Code: MQB FDA 510(k) #: K161730 5. Description of the Device [21 CFR 807.92(a)(4)] The CareView 3600RF detector is a class of radiography X-ray flat panel det… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 22 ancestors has a recall of any class.
- 3 other devices also cite its predicate K161730.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The CareView 3600RF detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography 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/K202995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202995: X-ray Flat Panel Detectors/CareView 3600RF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202995
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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