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 ×
15,695 results
1633–1656 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Mar 27, 2023
Overjet Caries Assist
K222746 · MYN
Overjet, Inc.
Radiology · 196d
Cleared Mar 22, 2023
MPXA-2000
K222036 · QIH
Medipixel, Inc.
Radiology · 254d
Cleared Mar 21, 2023
Syngo Carbon Space VA30A
K230561 · LLZ
Siemens Healthcare GmbH
Radiology · 21d
Cleared Mar 21, 2023
Nio Color 2MP (MDNC-2521)
K230520 · PGY
Barco N.V.
Radiology · 22d
Cleared Mar 21, 2023
FlightPlan for Embolization
K223490 · LLZ
GE Medical Systems SCS
Radiology · 120d
Cleared Mar 20, 2023
MOBINEURO Alita Intraoperative MRI System
K223875 · LNH
Sino Canada Health Engineering...
Radiology · 87d
Cleared Mar 20, 2023
P-Cure Proton Beam Therapy System
K221996 · LHN
P-Cure, Ltd.
Radiology · 257d
Cleared Mar 17, 2023
Viz AAA
K223443 · QFM
Viz. Ai, Inc.
Radiology · 123d
Cleared Mar 14, 2023
RT Elements (4.0)
K223279 · MUJ
Brainlab AG
Radiology · 141d
Cleared Mar 13, 2023
Aarhus Applicator Set
K222775 · JAQ
Varian Medical Systems, Inc.
Radiology · 180d
Cleared Mar 10, 2023
uMI Panorama
K223325 · KPS
Shanghai United Imaging Healthcare...
Radiology · 130d
Cleared Mar 09, 2023
Spectral Bone Marrow
K223514 · JAK
Ge Medical Systems, LLC
Radiology · 107d
Cleared Mar 09, 2023
AccuContour
K221706 · QKB
Manteia Technologies Co., Ltd.
Radiology · 269d
Cleared Mar 07, 2023
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
K223726 · JAK
Canon Medical Systems Corporation
Radiology · 84d
Cleared Mar 06, 2023
A1417MCW/A1717MCW/F1417MCW
K223930 · MQB
H&abyz Co., Ltd.
Radiology · 66d
Cleared Mar 03, 2023
CoverScan (CoverScan v1.1)
K230294 · LLZ
Perspectum
Radiology · 29d
Cleared Mar 03, 2023
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
K222819 · JAK
Canon Medical Systems Corporation
Radiology · 165d