Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Medical Solutions USA, Inc. · Predicate Candidate Screening
782 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
210 days90th percentile
782clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026-06-25 | 211 | 0 |
| K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | 2026-06-18 | 209 | 0 |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia S | Siemens Medical Solutions USA, Inc. | 2026-06-16 | 92 | 0 |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (113647 | Siemens Medical Solutions USA, Inc. | 2026-05-21 | 30 | 0 |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2026-04-29 | 127 | 0 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; | Siemens Medical Solutions USA, Inc. | 2026-04-24 | 122 | 0 |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | Siemens Medical Solutions USA, Inc. | 2026-04-23 | 149 | 0 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 | 123 | 0 |
| K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | 2026-02-10 | 57 | 0 |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Sele | Siemens Medical Solutions USA, Inc. | 2025-11-17 | 27 | 0 |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper | Siemens Medical Solutions USA, Inc. | 2025-11-13 | 38 | 0 |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | 2025-11-04 | 281 | 0 |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-10-15 | 125 | 0 |
| K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia | Siemens Medical Solutions USA, Inc. | 2025-08-20 | 99 | 0 |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | 2025-07-31 | 71 | 0 |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2025-07-29 | 74 | 0 |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM | Siemens Medical Solutions USA, Inc. | 2025-07-28 | 115 | 3 |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | 2025-07-09 | 54 | 0 |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.To | Siemens Medical Solutions USA, Inc. | 2025-07-03 | 107 | 0 |
| K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2025-07-03 | 45 | 0 |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | 2025-07-03 | 34 | 0 |
| K243145 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | 2025-04-10 | 192 | 0 |
| K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTO | Siemens Medical Solutions USA, Inc. | 2025-02-12 | 90 | 0 |
| K241757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-01-03 | 199 | 0 |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia | Siemens Medical Solutions USA, Inc. | 2024-11-19 | 88 | 0 |
| K243299 | ACUSON Redwood Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-11-15 | 28 | 0 |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364 | Siemens Medical Solutions USA, Inc. | 2024-10-30 | 30 | 0 |
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); | Siemens Medical Solutions USA, Inc. | 2024-10-22 | 144 | 11 |
| K241569 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2024-10-11 | 133 | 0 |
| K241295 | SOMATOM On.site | Siemens Medical Solutions USA, Inc. | 2024-09-03 | 118 | 0 |
| K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2024-08-30 | 29 | 0 |
| K242300 | MI View&GO | Siemens Medical Solutions USA, Inc. | 2024-08-30 | 28 | 0 |
| K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia | Siemens Medical Solutions USA, Inc. | 2024-07-22 | 130 | 0 |
| K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound Sy | Siemens Medical Solutions USA, Inc. | 2024-06-12 | 212 | 0 |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-06-12 | 212 | 0 |
| K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2024-04-26 | 227 | 0 |
| K240608 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | 2024-03-29 | 25 | 0 |
| K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | 2024-03-28 | 135 | 0 |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024-03-27 | 145 | 0 |
| K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.To | Siemens Medical Solutions USA, Inc. | 2024-03-26 | 133 | 1 |
| K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. | 2024-03-22 | 232 | 0 |
| K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2024-03-22 | 224 | 0 |
| K233748 | CIARTIC Move (VB10) | Siemens Medical Solutions USA, Inc. | 2024-03-15 | 114 | 0 |
| K232765 | MAGNETOM Cima.X Fit | Siemens Medical Solutions USA, Inc. | 2024-02-29 | 174 | 0 |
| K233677 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | 2024-01-12 | 57 | 0 |
| K232136 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | 2024-01-04 | 170 | 0 |
| K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | 2023-12-22 | 123 | 0 |
| K230955 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2023-12-20 | 260 | 0 |
| K231587 | MAGNETOM Cima.X | Siemens Medical Solutions USA, Inc. | 2023-12-18 | 201 | 1 |
| K230949 | ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. | 2023-12-15 | 255 | 2 |
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