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
2569–2592 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 15, 2020
SIGNA 7.0T
K201615 · LNH
Ge Medical Systems, LLC
Radiology · 122d
Cleared Oct 11, 2020
Quantib Prostate
K202501 · LLZ
Quantib B.V.
Radiology · 41d
Cleared Oct 11, 2020
syngo.CT Neuro Perfusion
K202213 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Oct 11, 2020
Voluson SWIFT, Voluson SWIFT+
K201828 · IYN
GE Medical Systems Ultrasound and...
Radiology · 101d
Cleared Oct 11, 2020
Yushan X-Ray Flat Panel Detector with DROC
K201528 · MQB
Innocare Optoelectronics Corp.
Radiology · 125d
Cleared Oct 08, 2020
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
K201972 · IYN
Canon Medical Systems Corporation
Radiology · 85d
Cleared Oct 08, 2020
31HN713D
K201777 · PGY
Lg Electronics.Inc
Radiology · 101d
Cleared Oct 08, 2020
IPS CaseDesigner
K200810 · LLZ
Nobel Biocare AB
Radiology · 195d
Cleared Oct 07, 2020
ScanX Edge
K202633 · MUH
D?rr Dental SE
Radiology · 26d
Cleared Oct 07, 2020
Radiographic System Challenge X
K202293 · KPR
Sedecal., Sa.
Radiology · 55d
Cleared Oct 07, 2020
AcuSee AS-P1000 System
K202119 · IYO
Weipeng (Suzhou) Medical Devices Co.,...
Radiology · 69d
Cleared Oct 05, 2020
Affirm Contrast Biopsy
K202294 · IZH
Hologic, Inc.
Radiology · 53d
Cleared Oct 05, 2020
UDE
K202292 · LLZ
Ebm Technologies, Inc.
Radiology · 54d
Cleared Oct 02, 2020
Cleerly Labs v2.0
K202280 · LLZ
Cleerly, Inc.
Radiology · 52d
Cleared Oct 02, 2020
LiverMultiScan
K202170 · LNH
Perspectum, Ltd.
Radiology · 60d
Cleared Sep 30, 2020
DigitalDiagnost C90
K202564 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 26d
Cleared Sep 30, 2020
e-Ortho Shoulder Software
K201928 · LLZ
FH Industrie
Radiology · 82d
Cleared Sep 30, 2020
Clear Guide SCENERGY
K201188 · JAK
Clear Guide Medical
Radiology · 152d
Cleared Sep 30, 2020
THINQ
K192051 · LLZ
Corticometrics, LLC
Radiology · 427d
Cleared Sep 29, 2020
LVivo Seamless
K202546 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 27d
Cleared Sep 25, 2020
Xeleris V Processing and Review Systems
K201103 · LLZ
Ge Healthcare
Radiology · 154d
Cleared Sep 24, 2020
GXR-Series Diagnostic X-Ray System
K202572 · KPR
DRGEM Corporation
Radiology · 20d
Cleared Sep 24, 2020
RayStation
K200569 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 204d
Cleared Sep 22, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K202210 · LNH
Canon Medical Systems Corporation
Radiology · 47d