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
6433–6456 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 21, 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830 · KPR
VATECH Co., Ltd.
Radiology · 310d
Cleared Jul 20, 2010
SOPIX 2
K092329 · MUH
Sopro
Radiology · 350d
Cleared Jul 19, 2010
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
K101455 · IYN
Medison Co., Ltd.
Radiology · 55d
Cleared Jul 16, 2010
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
K101829 · ITX
Medison Co., Ltd.
Radiology · 15d
Cleared Jul 16, 2010
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
K092713 · IZL
Transamerican Medical Imaging
Radiology · 316d
Cleared Jul 15, 2010
PACSMATE MMD-5201M MONITOR
K101796 · LLZ
Iei Technology Corp.
Radiology · 17d
Cleared Jul 15, 2010
FLAT PANEL DETECTOR, MODEL FDR D-EVO
K100762 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 120d
Cleared Jul 14, 2010
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
K101858 · MOS
Shanghai Chenguang Medical...
Radiology · 12d
Cleared Jul 13, 2010
VARIAN HIGH ENERGY LINEAR ACCELERATOR
K100890 · IYE
Varian Medical Systems
Radiology · 104d
Cleared Jul 12, 2010
SAVI PREPARATION DEVICE
K101411 · JAQ
Cianna Medical, Inc.
Radiology · 54d
Cleared Jul 12, 2010
VARIAN TREATMENT
K093967 · IYE
Varian Medical Systems, Inc.
Radiology · 201d
Cleared Jun 30, 2010
UROSKOP OMNIA
K101491 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 25, 2010
Z.ONE ULTRA ULTRASOUND SYSTEM
K101091 · IYN
Zonare Medical Systems, Inc.
Radiology · 67d
Cleared Jun 25, 2010
ZURA TEE SYSTEM WITH CLARITEE PROBE
K100989 · IYN
Imacor, Inc.
Radiology · 77d
Cleared Jun 25, 2010
MYLABTWICE, MODEL 6200
K100931 · IYN
Esaote, S.P.A.
Radiology · 81d
Cleared Jun 25, 2010
MOBIVISION
K100001 · MQB
Almana Medical Imaging
Radiology · 172d
Cleared Jun 23, 2010
8 CHANNEL CARDIAC PHASED ARRAY COIL
K101492 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 22d
Cleared Jun 23, 2010
MIRADA XD
K101228 · LLZ
Mirada Medical, Ltd.
Radiology · 51d
Cleared Jun 23, 2010
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT...
K100798 · FRN
Medrad, Inc.
Radiology · 93d
Cleared Jun 23, 2010
CORONIS FUSION 10MP, MODEL MDCG-10130
K093197 · LLZ
Barco N.V.
Radiology · 257d
Cleared Jun 23, 2010
CEDARA WEBACCESS, MODEL: 2.4
K092915 · LLZ
Cedara Software Corp.
Radiology · 274d
Cleared Jun 18, 2010
PUMA MODEL VERSION 1.0
K100801 · IYE
Prowess, Inc.
Radiology · 88d
Cleared Jun 18, 2010
BF-NAVI
K093810 · JAK
Kgt, Inc.
Radiology · 189d
Cleared Jun 17, 2010
FIDUCIAL MARKERS
K101131 · IYE
Cosman Medical, Inc.
Radiology · 56d