FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
1897–1920 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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 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