FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
961–984 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 17, 2024
MICSI-RMT
K241121 · LLZ
Microstructure Imaging, Inc.
Radiology · 85d
Cleared Jul 17, 2024
Rayvolve
K240845 · QBS
Azmed Sas
Radiology · 112d
Cleared Jul 17, 2024
Vitrea Software Package, VSTP-002A V2.0
K240705 · LLZ
Canon Medical Systems Corporation
Radiology · 125d
Cleared Jul 16, 2024
RadiForce RX670
K241441 · PGY
Eizo Corporation
Radiology · 55d
Cleared Jul 16, 2024
Swoop® Portable MR Imaging® System
K240944 · LNH
Hyperfine, Inc.
Radiology · 102d
Cleared Jul 15, 2024
NeuroLF (Basic)
K241751 · KPS
Positrigo AG
Radiology · 27d
Cleared Jul 12, 2024
BriefCase-Triage
K241727 · QAS
Aidoc Medical , Ltd.
Radiology · 28d
Cleared Jul 12, 2024
HiRise (1040-230)
K241713 · JAK
Curvebeam, LLC
Radiology · 28d
Cleared Jul 12, 2024
Acorn 3D Software (AC-SEG-4009)
K234009 · QIH
Mighty Oak Medical
Radiology · 206d
Cleared Jul 12, 2024
RUS
K233457 · QIH
Hutom, Inc.
Radiology · 266d
Cleared Jul 11, 2024
SubtleSYNTH (1.x)
K241329 · QIH
Subtle Medical, Inc.
Radiology · 62d
Cleared Jul 10, 2024
AOS Interstitial Templates, Needles, and Accessories
K233628 · JAQ
Alpha-Omega Services, Inc.
Radiology · 240d
Cleared Jul 05, 2024
DUO1 and DUO2
K241649 · MUH
Zinnovi, Inc.
Radiology · 28d
Cleared Jul 05, 2024
LifeRay Intraoral Handheld X-ray System
K241305 · EHD
Lucas Lifecare
Radiology · 57d
Cleared Jul 03, 2024
Transducer Probe Cover
K241615 · ITX
Hony Medical Co., Ltd.
Radiology · 28d
Cleared Jul 03, 2024
iQFlex Pro
K240009 · IZL
First Source, Inc.
Radiology · 183d
Cleared Jul 02, 2024
ViewPoint 6
K241300 · LLZ
Ge Healthcare GmbH
Radiology · 54d
Cleared Jul 02, 2024
SMART Bun-Yo-Matic X-Ray
K240736 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jul 02, 2024
AOS Marker Seeds (SMG0242-025)
K233626 · JAQ
Alpha-Omega Services, Inc.
Radiology · 232d
Cleared Jul 01, 2024
Hyper Insight - ICH
K240353 · QAS
Sk, Inc.
Radiology · 147d
Cleared Jul 01, 2024
cNeuro cDAT
K233908 · LLZ
Combinostics OY
Radiology · 202d
Cleared Jun 28, 2024
nordicMEDiVA
K241608 · LLZ
Nordicneurolab AS
Radiology · 24d
Cleared Jun 26, 2024
Magnifico Open (100009900)
K241133 · LNH
Esaote, S.P.A.
Radiology · 63d
Cleared Jun 26, 2024
SC1 Handheld Ultrasound Imaging system (Model: SC1)
K233579 · IYO
Fcu Co., Ltd.
Radiology · 232d