Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

810 results for "Siemens Medical Solutions USA, Inc."
1–24 of 810
Search insights Median review: 79d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 25, 2026
syngo.CT Brain Quantification
K260055 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 260d
Cleared Sep 10, 2026
ACUNAV Luxera 4D ICE Catheter
K261696 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 111d
Cleared Sep 01, 2026
MAGNETOM Free.Max
K260758 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 176d
Cleared Jul 31, 2026
MAGNETOM Flow.Elite
K260852 · LNH
Siemens Healthineers AG
Radiology · 137d
Cleared Jun 25, 2026
syngo.CT Coronary Cockpit
K253786 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 211d
Cleared Jun 18, 2026
MAMMOMAT B.brilliant (11372950)
K253678 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 209d
Cleared Jun 16, 2026
ACUSON Sequoia Diagnostic Ultrasound System
K260844 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 92d
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared May 21, 2026
Symbia Pro.specta Q3 (11364751)
K261315 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Apr 29, 2026
syngo Application Software
K254184 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 127d
Cleared Apr 24, 2026
ARTIS icono floor
K254173 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Apr 23, 2026
ARTIS genio floor
K253752 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 149d
Cleared Mar 20, 2026
SOMATOM X.cite
K253574 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Feb 23, 2026
MAGNETOM Flow.Ace
K260265 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 26d
Cleared Feb 10, 2026
MI View&GO
K254016 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Jan 15, 2026
BIOGRAPH One
K253023 · OUO
Siemens Healthineers AG
Radiology · 118d
Cleared Dec 19, 2025
MAGNETOM Sola
K252838 · LNH
Siemens Healthcare GmbH
Radiology · 105d
Cleared Nov 20, 2025
MAGNETOM Free.Max
K251822 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 160d
Cleared Nov 17, 2025
ACUSON Maple Diagnostic Ultrasound System
K253487 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Nov 13, 2025
ACUSON Juniper Diagnostic Ultrasound System
K253457 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 38d
Cleared Nov 04, 2025
Cios Select
K250241 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 281d
Cleared Oct 15, 2025
syngo.CT Dual Energy
K251805 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Aug 20, 2025
ACUSON Sequoia Diagnostic Ultrasound System
K251481 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 99d
Cleared Jul 31, 2025
Biograph Trinion
K251561 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 71d