Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUH · Predicate Candidate Screening
206 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
231 days90th percentile
206clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | 2026-03-03 | 265 | 0 |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | 2025-11-10 | 88 | 0 |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | 2025-10-24 | 232 | 0 |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | 2025-09-24 | 159 | 0 |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (Vi | VATECH Co., Ltd. | 2024-10-25 | 294 | 0 |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | 2024-10-11 | 28 | 0 |
| K241649 | DUO1 and DUO2 | Zinnovi, Inc. | 2024-07-05 | 28 | 0 |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024-04-18 | 259 | 0 |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | 2023-12-20 | 196 | 0 |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Senso | Dental Imaging Technologies Corporation | 2023-11-21 | 57 | 0 |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | 2023-10-20 | 58 | 0 |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023-10-20 | 196 | 0 |
| K230916 | WeSensor | Picopack, Inc. | 2023-10-10 | 190 | 0 |
| K232255 | EZSensor XHD | Qpix Solutions, Inc. | 2023-09-27 | 61 | 0 |
| K232158 | GenX-CR | Genoray Co., Ltd. | 2023-09-13 | 55 | 0 |
| K231202 | QuickRayPRO | Denterprise International, Inc. | 2023-06-22 | 56 | 0 |
| K230811 | Digital Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023-04-21 | 28 | 0 |
| K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | 2023-04-11 | 26 | 0 |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | 2023-02-06 | 25 | 0 |
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler G | Realcloud Imaging Inc. Dba Realcloud Imaging | 2022-08-31 | 57 | 0 |
| K221008 | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) | Shanghai Handy Medical Equipment Co., Ltd. | 2022-06-22 | 78 | 0 |
| K220423 | PAPAYA & PAPAYA Plus | Genoray Co., Ltd. | 2022-05-19 | 94 | 0 |
| K220556 | OpenSensorX Series | Dentimax, Inc. | 2022-04-13 | 44 | 0 |
| K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang , Ltd. | 2022-03-11 | 25 | 0 |
| K214091 | Dental Image Plate Scanner, Model DFC-4T-SMART | Hefei Dentafilm Medical Equipment Co., Ltd. | 2022-03-02 | 64 | 0 |
| K220277 | Digital Intraoral X-ray Sensor | Shenzhen Xpectvision Technology Co., Ltd. | 2022-02-17 | 17 | 0 |
| K213637 | JAZZ Solo sensor | Jazz Imaging, LLC Dba Jazz Imaging | 2021-12-10 | 22 | 0 |
| K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | 2021-10-07 | 79 | 0 |
| K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-09-27 | 87 | 0 |
| K202369 | RXS 1000 | Rolence Enterprise, Inc. | 2021-09-15 | 392 | 0 |
| K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | Fona S.R.L | 2021-08-30 | 55 | 0 |
| K211317 | CRUXVIEW | Cruxell Corp. | 2021-07-29 | 90 | 0 |
| K211688 | DC-Air and Athlos-1 and Athlos-Air | Athlos OY | 2021-07-22 | 50 | 0 |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | 2021-04-23 | 79 | 0 |
| K203116 | SensorX | Durr Dental SE | 2021-03-19 | 154 | 0 |
| K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade m | De Götzen S.R.L. | 2021-02-05 | 81 | 0 |
| K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. Dba Sota Imaging | 2020-11-06 | 53 | 0 |
| K202633 | ScanX Edge | Dürr Dental SE | 2020-10-07 | 26 | 0 |
| K200625 | I-View Gold and Imagen Gold Dental Sensors | Trident S.R.L | 2020-04-15 | 36 | 0 |
| K200284 | R-Sensor, R-Sensor | Remedi Co., Ltd. | 2020-02-28 | 23 | 0 |
| K191719 | X-MIND Trium | De Gotzen S.R.L. | 2020-02-20 | 239 | 0 |
| K192766 | Digital Intraoral Imaging Plate System | Fsusen Technology Co., Ltd. | 2019-12-05 | 66 | 0 |
| K191623 | ScanX Touch/ScanX Duo Touch | Air Techniques, Inc. | 2019-08-21 | 64 | 0 |
| K190234 | ODI HD Dental Sensor | Cnd Global Technologies, Inc. | 2019-03-01 | 23 | 0 |
| K183637 | Cruxcan (CRX-1000) | Cruxell Corp. | 2019-02-12 | 48 | 0 |
| K182198 | Panoura X-ERA PF/NF/MF | The Yoshida Dental Mfg. Co., Ltd. | 2019-01-31 | 170 | 0 |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018-11-21 | 189 | 0 |
| K181636 | Aurora | Sodium Systems, LLC | 2018-07-20 | 29 | 0 |
| K181358 | Televere Digital Dental Imaging System | Televere Systems, Inc. | 2018-06-20 | 29 | 0 |
| K173646 | FS Ergo | Palodex Group OY | 2017-12-19 | 22 | 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