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

Filters: Radiology × Cleared only ×
15,676 results
1609–1632 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 10, 2023
ARIA Radiation Therapy Management (v18.0)
K230699 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Apr 10, 2023
DMX
K223550 · KPR
Del Medical, Inc.
Radiology · 136d
Cleared Apr 07, 2023
Limbus Contour
K230575 · LLZ
Limbus Ai, Inc.
Radiology · 37d
Cleared Apr 07, 2023
Dental CT Scanner AXR
K223816 · OAS
Alliage S/A Industrias Medico...
Radiology · 108d
Cleared Apr 06, 2023
Contour ProtégéAI
K223774 · QKB
Mim Software, Inc.
Radiology · 111d
Cleared Apr 06, 2023
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700...
K223458 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 141d
Cleared Apr 06, 2023
AI-Rad Companion (Cardiovascular)
K222360 · JAK
Siemens Medical Solutions U.S.A.
Radiology · 245d
Cleared Apr 03, 2023
Annalise Enterprise CTB Triage Trauma
K223240 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 165d
Cleared Mar 31, 2023
Iris AirShuttle™
K230312 · IYE
Qfix
Radiology · 56d
Cleared Mar 31, 2023
SonoAir Series Digital Color Doppler Ultrasound System
K223570 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 122d
Cleared Mar 31, 2023
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
K223017 · IYN
Canon Medical Systems Corporation
Radiology · 183d
Cleared Mar 31, 2023
Butterfly iQ/iQ+ Ultrasound System
K220068 · IYO
Butterfly Network, Inc.
Radiology · 445d
Cleared Mar 31, 2023
RadAlly
K213660 · LLZ
Imaging Wave, LLC
Radiology · 494d
Cleared Mar 31, 2023
Formus Hip
K213272 · QIH
Formus Labs, Ltd.
Radiology · 547d
Cleared Mar 31, 2023
CereFlow™ V1.2
K211059 · LLZ
Translational Mri, LLC
Radiology · 721d
Cleared Mar 30, 2023
Emory Cardiac Toolbox 4.3
K223422 · KPS
Syntermed
Radiology · 136d
Cleared CT Mar 30, 2023
Comfort Marker 2.0
K222112 · QRN
Medical Precision BV
Radiology · 255d
Cleared Mar 29, 2023
RayStation 12A
K222312 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 240d
Cleared Mar 29, 2023
InterView XP
K221984 · LLZ
Mediso Medical Imaging Systems, Lttd.
Radiology · 266d
Cleared Mar 28, 2023
MAGNETOM Amira
K223343 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 147d
Cleared Mar 28, 2023
Annalise Enterprise CXR Triage Trauma
K222268 · QFM
Annalise-Ai Pty , Ltd.
Radiology · 243d
Cleared Mar 28, 2023
Annalise Enterprise CXR Triage Trauma
K222179 · QFM
Annalise-Ai Pty , Ltd.
Radiology · 249d
Cleared Mar 28, 2023
RadioLens v1.0
K222174 · QIH
Synapsica
Radiology · 250d
Cleared Mar 28, 2023
DTX Studio Clinic 3.0
K221921 · MYN
Nobel Biocare AB
Radiology · 270d