Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IZL — Predicate Candidate Screening
237 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
183 days90th percentile
237clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260236 | XLITE | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 | 189 | 0 |
| K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-06-18 | 269 | 0 |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | 2026-05-14 | 122 | 0 |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-R | Carestream Health | 2026-03-11 | 166 | 0 |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mi | Poskom Co., Ltd. | 2026-02-23 | 147 | 0 |
| K250976 | Airbile-100 | Poskom Co., Ltd. | 2025-12-19 | 263 | 0 |
| K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | 2025-10-24 | 143 | 0 |
| K243864 | BONX805 | Bontech Co., Ltd. | 2025-09-12 | 269 | 0 |
| K251443 | PROMO | DRGEM Corporation | 2025-08-22 | 105 | 0 |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | 2025-08-04 | 105 | 0 |
| K250597 | REMEX Xcam6 | Remedi, Inc. | 2025-07-31 | 153 | 0 |
| K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | 2025-07-29 | 263 | 0 |
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | 2025-07-18 | 128 | 0 |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | 2025-05-28 | 148 | 0 |
| K241980 | !M1 | Solutions For Tomorrow AB | 2025-05-06 | 305 | 0 |
| K241996 | ULTRA 1040 | Ecoray Co., Ltd. | 2025-04-18 | 283 | 0 |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | 2024-12-16 | 159 | 0 |
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2024-12-10 | 196 | 0 |
| K240841 | Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. | 2024-12-09 | 257 | 0 |
| K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 | 48 | 0 |
| K242651 | GM85 | Samsung Electronics Co., Ltd. | 2024-10-01 | 27 | 0 |
| K234108 | ERI Portable X-ray System (CVX-air); ERI Portable X-ray Syst | Energy Resources International Co., Ltd. | 2024-09-20 | 268 | 0 |
| K240009 | iQFlex Pro | First Source, Inc. | 2024-07-03 | 183 | 0 |
| K240284 | Digital Radiography System (MobileApex 60E, MobileApex 60F, | Shenzhen Browiner Tech Co., Ltd. | 2024-03-28 | 56 | 0 |
| K233678 | Radiography 7000 M | Philips Medical Systems Dmc GmbH | 2024-02-14 | 90 | 0 |
| K232185 | SM-IV | Sedecal., Sa. | 2023-08-21 | 28 | 0 |
| K230581 | TOPA12 Portable X-ray Unit | Neuf, Inc. | 2023-08-16 | 167 | 0 |
| K231577 | MOBILETT Impact | Siemens Medical Solutions | 2023-07-25 | 55 | 0 |
| K222896 | AirRay | Poskom Co., Ltd. | 2022-12-20 | 88 | 0 |
| K222951 | SM-V | Sedecal., Sa. | 2022-11-21 | 55 | 0 |
| K222258 | Combined High Frequency X-ray Source | Suzhou Powersite Electric Co., Ltd. | 2022-11-01 | 97 | 0 |
| K222339 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 | 58 | 0 |
| K222353 | GM85 | Samsung Electronics Co., Ltd. | 2022-09-29 | 56 | 3 |
| K221417 | CLAROX plus (Model: VX-100) | Vsi Co., Ltd. | 2022-09-13 | 120 | 0 |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Sedecal., Sa. | 2022-07-18 | 26 | 1 |
| K213405 | MINE ALNU (Model: Mine 2.1) | Hdt Co., Ltd. | 2022-07-10 | 264 | 0 |
| K221081 | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System | First Source, Inc. | 2022-06-13 | 62 | 1 |
| K220700 | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-r | Yian Medical Technology (Haining) Co., Ltd. | 2022-05-04 | 55 | 0 |
| K220175 | GM85 | Samsung Electronics Co., Ltd. | 2022-04-21 | 90 | 0 |
| K220678 | APX-24 Portable X-ray System | Aspenstate, Inc. | 2022-03-31 | 23 | 0 |
| K213568 | DRX-Rise Mobile X-ray System | Carestream Health | 2022-03-23 | 134 | 0 |
| K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | 2022-03-04 | 170 | 0 |
| K213462 | EzRay M18 (Model: VMX-P400) | VATECH Co., Ltd. | 2022-02-11 | 107 | 0 |
| K212654 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2022-02-04 | 165 | 0 |
| K212515 | MOVIX DReamy | Stephanix | 2021-11-03 | 85 | 0 |
| K212291 | PHOENIX | Sedecal., Sa. | 2021-09-14 | 54 | 1 |
| K212134 | Diagnostic X-ray System/PLX5200A | Nanjing Perlove Medical Equipment Co., Ltd. | 2021-08-25 | 48 | 0 |
| K211383 | NFLK-2501 Portable X-ray Unit | Neuf, Inc. | 2021-08-13 | 101 | 0 |
| K212144 | Remex KA6 | Remedi Co., Ltd. | 2021-08-03 | 25 | 0 |
| K211473 | Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2021-06-04 | 23 | 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