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
1969–1992 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 06, 2022
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K220358 · IYN
GE Medical Systems Ultrasound and...
Radiology · 118d
Cleared Jun 03, 2022
BriefCase
K221314 · QAS
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Jun 03, 2022
21HQ613D
K221061 · PGY
Lg Electronics.Inc
Radiology · 53d
Cleared Jun 03, 2022
3D Anatomic Models
K220205 · LLZ
Ricoh USA, Inc.
Radiology · 129d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Fujifilm Corporation
Radiology · 157d
Cleared Jun 03, 2022
TrueBeam, TrueBeam STx, Edge, VitalBeam
K213977 · IYE
Varian Medical Systems, Inc.
Radiology · 165d
Cleared Jun 02, 2022
Rayvolve
K220164 · QBS
Azmed Sas
Radiology · 133d
Cleared May 31, 2022
EchoNavigator R4.0
K221270 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared May 31, 2022
Rapid LVO
K221248 · QAS
Ischemaview, Inc.
Radiology · 29d
Cleared May 31, 2022
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
K213731 · KPS
Ever Fortune.Ai, Co., Ltd.
Radiology · 186d
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