Siemens Medical Solutions USA, Inc.: FDA clearances and approvals
Siemens Medical Solutions USA, Inc. has 784 FDA 510(k) clearances (first 1980, latest 2026), plus 3 PMA decisions, across 82 product codes in 9 review panels. Median 510(k) review time: 80 days. Since 2017 its median was 86 days, against 122 days for all cleared 510(k)s in the same product codes. openFDA lists 1,245 product recalls by a recalling firm named Siemens Medical Solutions USA, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 15 | 36 |
| 2013 | 26 | 76 |
| 2014 | 30 | 93 |
| 2015 | 23 | 110 |
| 2016 | 21 | 93 |
| 2017 | 26 | 72 |
| 2018 | 25 | 104 |
| 2019 | 23 | 78 |
| 2020 | 32 | 77 |
| 2021 | 24 | 55 |
| 2022 | 30 | 72 |
| 2023 | 24 | 128 |
| 2024 | 22 | 133 |
| 2025 | 15 | 90 |
| 2026 | 11 | 123 |
Review time against the same product codes
Since 2017, Siemens Medical Solutions USA, Inc.'s cleared 510(k)s took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 135 | 135 |
| JAK | System, X-Ray, Tomography, Computed | 105 | 105 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 75 | 75 |
| LLZ | System, Image Processing, Radiological | 74 | 74 |
| KPS | System, Tomography, Computed, Emission | 46 | 46 |
| OWB | Interventional Fluoroscopic X-Ray System | 37 | 37 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 31 | 31 |
| DSI | Detector And Alarm, Arrhythmia | 27 | 27 |
| IYE | Accelerator, Linear, Medical | 18 | 18 |
| KPR | System, X-Ray, Stationary | 14 | 14 |
Plus 72 more product codes.
Review panels
- Radiology (667)
- Cardiovascular (80)
- Anesthesiology (16)
- Gastroenterology and Urology (3)
- Dental (2)
- Neurology (2)
- Obstetrics and Gynecology (2)
- General and Plastic Surgery (2)
- Orthopedic (1)
Most recent Siemens Medical Solutions USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261696 | ACUNAV Luxera 4D ICE Catheter | OBJ | 2026-09-10 | 111 |
| K260488 | MULTIX Impact; MULTIX Impact C | KPR | 2026-08-31 | 199 |
| K253786 | syngo.CT Coronary Cockpit | QIH | 2026-06-25 | 211 |
| K253678 | MAMMOMAT B.brilliant (11372950) | MUE | 2026-06-18 | 209 |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | IYN | 2026-06-16 | 92 |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | KPS | 2026-05-21 | 30 |
| K254184 | syngo Application Software | QIH | 2026-04-29 | 127 |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | OWB | 2026-04-24 | 122 |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | OWB | 2026-04-23 | 149 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | JAK | 2026-03-20 | 123 |
774 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P140011 | PMA | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION | 2015-04-21 |
| P050022 | PMA | SYNGO LUNG CAD | 2006-10-18 |
| P010039 | PMA | SIEMENS SONOCUR BASIC SYSTEM | 2002-07-19 |
Recalls
1,245 product recalls in 618 recall events; 162 initiated in the last five years. Most recent: 2026-06-08.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Siemens Medical Solutions USA, Inc.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNI)
Frequently asked questions
How many FDA 510(k) clearances does Siemens Medical Solutions USA, Inc. have?
Siemens Medical Solutions USA, Inc. has 784 FDA 510(k) clearances (first 1980, latest 2026), plus 3 PMA decisions, across 82 product codes in 9 review panels.
How long does FDA take to clear Siemens Medical Solutions USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Siemens Medical Solutions USA, Inc.'s cleared 510(k)s is 80 days. Since 2017: 86 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does Siemens Medical Solutions USA, Inc. make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 135); JAK (System, X-Ray, Tomography, Computed, 105); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 75).
Has Siemens Medical Solutions USA, Inc. had device recalls?
openFDA lists 1,245 product recalls in 618 recall events by a recalling firm whose name matches Siemens Medical Solutions USA, Inc; the most recent began 2026-06-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 784 Siemens Medical Solutions USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Siemens Medical Solutions USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.