Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MWP — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
176 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (Tr | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 | 96 | 0 |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 20 | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 | 96 | 0 |
| K213691 | Solas OR | Cirdan Imaging, Ltd. | 2021-12-22 | 29 | 0 |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021-09-20 | 174 | 0 |
| K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | 2021-08-31 | 154 | 0 |
| K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | 2021-08-31 | 154 | 0 |
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020-11-18 | 63 | 0 |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | 2020-06-12 | 80 | 0 |
| K192939 | Volumetric Specimen Imager | Clarix Imaging | 2019-12-27 | 70 | 0 |
| K193317 | CoreLite X-Ray Specimen Cabinet | Cirdan Imaging Limited | 2019-12-13 | 14 | 0 |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | 2019-06-20 | 176 | 0 |
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | 2019-03-14 | 121 | 0 |
| K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019-01-10 | 104 | 0 |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018-05-09 | 203 | 0 |
| K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017-07-18 | 124 | 0 |
| K153583 | BioVision Plus | Faxitron Bioptics, LLC | 2016-04-01 | 108 | 0 |
| K122428 | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | Faxitron Bioptics, LLC | 2012-09-25 | 47 | 0 |
| K111508 | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 | Hologic, Inc. | 2011-08-19 | 79 | 0 |
| K091928 | 10 X 10 VISION | Bioptics, Inc. | 2010-06-16 | 351 | 0 |
| K091558 | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | Bioptics, Inc. | 2009-07-17 | 50 | 0 |
| K082432 | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2008-11-21 | 91 | 0 |
| K072557 | FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 | Faxitron X-Ray Corp. | 2007-10-30 | 49 | 0 |
| K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | Kub Technologies, Inc. | 2007-06-20 | 48 | 0 |
| K061361 | FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 | Faxitron X-Ray Corp. | 2006-08-15 | 91 | 0 |
| K052433 | PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2005-10-18 | 42 | 0 |
| K021113 | MAMMOPATH | Fischer Imaging Corp. | 2002-06-13 | 69 | 0 |
| K852634 | MICRO-FOCUS 50 CABINET X-RAY | Micro-Focus Imaging., Inc. | 1985-07-19 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda