510(k) · Cleared
ClearedTrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compai Healthcare (Suzhou) Co.,Ltd · MWP Cabinet, X-Ray System
Cleared on Apr 24, 2023 as substantially equivalent to K202713 (Compai Healthcare (Shenzhen) Co.,Ltd, 2020) after a 96-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Apr 24, 2023
- Review
- 96 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K021113 (2002). 9 ancestors in all, the oldest K953404 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 6 generations backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- 5 generations backK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- 4 generations backK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- 3 generations backK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- 2 generations backK182727 Trident HD Specimen Radiography SystemHologic, Inc. · 2019
- 1 generation backK202713 TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd · 2020
- This deviceK230136 TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,Ltd · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −6 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| −5 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| −4 | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| −3 | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| −2 | K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019 | — |
| −1 | K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020 | — |
| 0 (this device) | K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 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 MWP? 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 MWP device
- #1 K202713 TrueView 100 Proscore 7.9 · 6 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 |
|---|---|---|---|
| * | K202713 | TrueView 100 ProSummary page 5…s: Class II Review Panel: Radiology Submitter/510(k) Holder: CompAI Healthcare (Shenzhen) Co., Ltd Clearance: K202713 1 CompAI Healthcare (Suzhou) Co.,ltd Room 3A05, Building 2, No.8 Chang… | 2020 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K202713.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MWP
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MWP
154in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWP
No recall names MWP since 2007.
Adverse event reports per year · MWP
1in 2025
MAUDE reports naming product code MWP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 5 | 104 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 154 | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230136 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230136: TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230136
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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