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
3001–3024 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 25, 2019
PhoeniX
K192011 · IZL
Sedecal., Sa.
Radiology · 58d
Cleared Sep 20, 2019
syngo.CT Extended Functionality
K192402 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Sep 20, 2019
Merge Cardio
K192276 · LLZ
Merge Healthcare Incorporated
Radiology · 29d
Cleared Sep 20, 2019
CivaDerm
K191324 · KXK
Civatech Oncology, Inc.
Radiology · 127d
Cleared Sep 20, 2019
SeeFactorCT3
K190856 · OAS
Epica International, Inc.
Radiology · 171d
Cleared Sep 19, 2019
RS80 EVO Diagnostic Ultrasound System
K192030 · IYN
Samsung Medison Co., Ltd.
Radiology · 51d
Cleared Sep 19, 2019
GEHC DXA Bone Densitometers with enCORE version 18
K191112 · KGI
GE Medical Systems Ultrasound &...
Radiology · 146d
Cleared Sep 18, 2019
InnoSight Diagnostic Ultrasound System
K192254 · IYN
Qisda Corporation
Radiology · 29d
Cleared Sep 18, 2019
Syngo.Via RT Image Suite
K192065 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Sep 18, 2019
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
K191663 · IYN
Canon Medical Systems Corporation
Radiology · 89d
Cleared Sep 16, 2019
SubtleMR
K191688 · LLZ
Subtle Medical, Inc.
Radiology · 84d
Cleared Sep 13, 2019
SIS Software Version 3.6.0
K192304 · LLZ
Surgical Information Sciences, Inc.
Radiology · 21d
Cleared Sep 13, 2019
PROBEAT-CR
K191801 · LHN
Hitachi , Ltd.
Radiology · 72d
Cleared Sep 13, 2019
SCENARIA View
K190841 · JAK
Hitachi Healthcare Americas
Radiology · 165d
Cleared Sep 12, 2019
uDR 592h, uDR 596i
K192293 · KPR
Shanghai United Imaging Healthcare...
Radiology · 20d
Cleared Sep 12, 2019
CRC PC Smart Chamber K1
K192199 · KPT
Capintec, Inc.
Radiology · 30d
Cleared Sep 12, 2019
syngo Application Software
K190780 · LLZ
Siemens Medical Solution USA, Inc.
Radiology · 169d
Cleared Sep 12, 2019
ARTIS icono
K190768 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 170d
Cleared Sep 10, 2019
AI-Rad Companion (Cardiovascular)
K183268 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 291d
Cleared Sep 09, 2019
Encompass 15 Channel Head Coil, 3T
K190668 · MOS
Qfix
Radiology · 178d
Cleared Sep 06, 2019
Lumify Diagnostic Ultrasound System
K192226 · IYN
Philips Health Care
Radiology · 21d
Cleared Sep 06, 2019
Aquilion ONE (TSX-306A/3) V10.0
K192188 · JAK
Canon Medical Systems Corporation
Radiology · 24d
Cleared Sep 06, 2019
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive...
K191845 · PGY
Barco N.V.
Radiology · 58d
Cleared Sep 04, 2019
MobileRay Pulse SE Digital Imaging System
K191503 · OWB
Portavision Medical, LLC
Radiology · 90d