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
1969–1992 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 27, 2022
Aspire Cristalle
K212873 · MUE
Fujifilm Corporation
Radiology · 260d
Cleared CT May 26, 2022
Barrigel Injectable Gel
K220641 · OVB
Palette Life Sciences
Radiology · 83d
Cleared May 25, 2022
SwiftMR
K220416 · LLZ
Airs Medical, Inc.
Radiology · 100d
Cleared May 23, 2022
ON3D
K221000 · LLZ
3D Ons, Inc.
Radiology · 49d
Cleared May 23, 2022
SCENARIA View
K213829 · JAK
Fujifilm Healthcare Corporation
Radiology · 166d
Cleared May 20, 2022
syngo Dynamics (Version VA40E)
K220832 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 59d
Cleared May 19, 2022
PAPAYA & PAPAYA Plus
K220423 · MUH
Genoray Co., Ltd.
Radiology · 94d
Cleared May 19, 2022
PAPAYA 3D & PAPAYA 3D Plus
K220392 · OAS
Genoray Co., Ltd.
Radiology · 97d
Cleared May 19, 2022
CoverScan v1
K212565 · LLZ
Perspectum, Ltd.
Radiology · 279d
Cleared May 17, 2022
BriefCase
K221240 · QAS
Aidoc Medical , Ltd.
Radiology · 18d
Cleared May 17, 2022
syngo.CT CaScoring
K221219 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared May 17, 2022
MULTIX Impact E
K220919 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared May 17, 2022
Rapid PE Triage and Notification (PETN)
K220499 · QAS
Ischemaview, Inc.
Radiology · 84d
Cleared May 17, 2022
Monaco RTP System
K213787 · MUJ
Elekta Solutions AB
Radiology · 162d
Cleared May 16, 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K213583 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 185d
Cleared May 16, 2022
Caas Qardia
K212376 · LLZ
Pie Medical Imaging BV
Radiology · 290d
Cleared May 16, 2022
SONON Ultrasound Imaging System, Model: SONON300C
K211665 · IYN
Healcerion Co., Ltd.
Radiology · 349d
Cleared May 13, 2022
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
K221144 · MQB
Radisen Co., Ltd.
Radiology · 23d
Cleared May 13, 2022
XACT ACE Robotic System
K221116 · JAK
Xact Robotics, Ltd.
Radiology · 28d
Cleared May 13, 2022
Quantib Prostate
K221106 · LLZ
Quantib B.V.
Radiology · 28d
Cleared May 13, 2022
MAGNETOM Skyra Fit
K220589 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared May 13, 2022
INTDose
K213137 · IYE
Carina Medical, LLC
Radiology · 228d
Cleared May 13, 2022
Spectral CT on Rails
K212875 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 246d
Cleared May 12, 2022
Saige-Dx
K220105 · QDQ
DeepHealth, Inc.
Radiology · 120d