Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JAK — Predicate Candidate Screening
822 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
232 days90th percentile
822clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | 2026-07-28 | 299 | 0 |
| K253770 | CardIQ Suite | GE Medical Systems SCS | 2026-07-21 | 237 | 0 |
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026-06-24 | 219 | 0 |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026-06-04 | 258 | 0 |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026-05-20 | 183 | 0 |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 | 127 | 0 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 | 122 | 0 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 | 186 | 0 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 | 128 | 0 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 | 123 | 0 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 | 60 | 0 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 | 238 | 0 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 | 45 | 0 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 | 45 | 0 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 | 44 | 0 |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 | 116 | 0 |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | 2025-11-28 | 136 | 0 |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-10-15 | 125 | 0 |
| K250662 | Bunkerhill MAC | BunkerHill Health | 2025-10-03 | 212 | 0 |
| K250766 | LungQ 4 | Thirona BV | 2025-10-02 | 203 | 0 |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8 | Canon Medical Systems Corporation | 2025-09-26 | 120 | 0 |
| K250928 | OmniTom Elite with PCD | Neurologica Corporation | 2025-09-08 | 164 | 0 |
| K251484 | CT:VQ | 4Dmedical Limited | 2025-08-28 | 106 | 0 |
| K250941 | Revolution Vibe | Ge Medical Systems, LLC | 2025-08-01 | 126 | 0 |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM | Siemens Medical Solutions USA, Inc. | 2025-07-28 | 115 | 3 |
| K250970 | Marie | Leo Cancer Care | 2025-07-25 | 116 | 0 |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.To | Siemens Medical Solutions USA, Inc. | 2025-07-03 | 107 | 0 |
| K250648 | Philips iCT CT system | Philips Medical Systems Nederland B.V. | 2025-06-27 | 115 | 2 |
| K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | 2025-06-20 | 232 | 0 |
| K243672 | CardIQ Suite | GE Medical Systems SCS | 2025-06-18 | 203 | 0 |
| K250370 | SCENARIA View Phase 5.0 | Fujifilm Corporation | 2025-05-20 | 99 | 0 |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLA | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 | 175 | 1 |
| K244008 | Spectral CT | Philips Medical Systems Technologies , Ltd. | 2025-05-16 | 141 | 1 |
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screenin | Arineta , Ltd. | 2025-04-15 | 42 | 0 |
| K243240 | Vitrea CT VScore | Canon Medical Informatics, Inc. | 2025-04-10 | 182 | 0 |
| K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | 2025-03-14 | 177 | 0 |
| K242411 | Brainomix 360 e-Lung | Brainomix Limited | 2025-02-19 | 189 | 0 |
| K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTO | Siemens Medical Solutions USA, Inc. | 2025-02-12 | 90 | 0 |
| K243229 | Bunkerhill AVC | BunkerHill Health | 2025-01-27 | 111 | 0 |
| K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-14 | 263 | 0 |
| K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening | Arineta , Ltd. | 2025-01-13 | 258 | 0 |
| K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-07 | 263 | 1 |
| K241757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-01-03 | 199 | 0 |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024-12-23 | 132 | 0 |
| K242188 | ClearRead CT CAC | Riverain Technologies, Inc. | 2024-12-03 | 131 | 0 |
| K242874 | Gating Reflector Block | Varian Medical Systems, Inc. | 2024-11-21 | 59 | 0 |
| K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies , Ltd. | 2024-10-18 | 205 | 0 |
| K240369 | CAC (gated) Algorithm | BunkerHill Health | 2024-09-27 | 233 | 0 |
| K241295 | SOMATOM On.site | Siemens Medical Solutions USA, Inc. | 2024-09-03 | 118 | 0 |
| K241440 | HealthCCSng | Nano-X AI , Ltd. | 2024-08-19 | 90 | 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