510(k) · Cleared
ClearedCareView 1800Le
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 Dec 13, 2019 as substantially equivalent to K153492 (Careray Digital Medical System Co., Ltd., 2015) after a 25-day review. Its family tree reaches back 10 generations to 1981. 4 later devices descend from it.
- Decided
- Dec 13, 2019
- Review
- 25 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K803130 (1981). 27 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations between
- 3 generations backK150929 CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015
- 2 generations backK153058 CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015
- 1 generation backK153492 CareView 1800LCareray Digital Medical System Co., Ltd. · 2015
- This deviceK193173 CareView 1800LeCareray Digital Medical System Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK221549 X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK223687 X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK232058 YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK201932 X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 9 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 7 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 6 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 5 generations backK120020 Vivix-SVieworks Co., Ltd. · 2012
- 4 generations backK122865 Vivix-S WirelessVieworks Co., Ltd. · 2013
- 3 generations backK150929 CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015
- 2 generations backK153058 CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. · 2015
- 1 generation backK153492 CareView 1800LCareray Digital Medical System Co., Ltd. · 2015
- This deviceK193173 CareView 1800LeCareray Digital Medical System Co., Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd. · 2022 · cites it directly2descendants
- K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd. · 2023 · 3 generations on0descendants
- K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −9 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −8 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −7 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −6 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K120020 | Vivix-S | Vieworks Co., Ltd. | 2012 | — |
| −4 | K122865 | Vivix-S Wireless | Vieworks Co., Ltd. | 2013 | — |
| −3 | K150929 | CareView 1500Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015 | — |
| −2 | K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015 | — |
| −1 | K153492 | CareView 1800L | Careray Digital Medical System Co., Ltd. | 2015 | — |
| 0 (this device) | K193173 | CareView 1800Le | Careray Digital Medical System Co., Ltd. | 2019 | — |
| +1 | K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | Careray Digital Medical Technology Co., Ltd. | 2022 | — |
| +2 | K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | 2022 | — |
| +3 | K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | 2023 | — |
| +1 | K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | Careray Digital Medical System Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K153492 | CareView 1800LSummary page 6…Page 2 of 6 Regulatory Class: Class II Product Code: MQB FDA 510(k) #: K153492 5. Description of the Device [21 CFR 807.92(a)(4)] The CareView 1800Le detector is a class of digital X-ray flat panel detecto… | 2015 |
What descends from it? (4)
2 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?
- The line of descent spans 38 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 27 ancestors have a recall of any class.
- Of its descendants, K221549 (Careray Digital Medical Technology Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
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. 2019, 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 1800Le 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 as stated in the FDA summary.
https://510kreport.com/device/K193173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193173: CareView 1800Le.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193173
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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