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
8761–8784 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329 · IYN
Medison America, Inc.
Radiology · 8d
Cleared Aug 04, 2003
SQUEEZE-EASE MAMMOGRAPHY CUSHION
K031574 · IZH
S & S X-Ray Products, Inc.
Radiology · 76d
Cleared Aug 01, 2003
R 72
K030487 · KPW
Ralco S.R.L.
Radiology · 168d
Cleared Aug 01, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
K032202 · LLZ
Planar Systems, Inc.
Radiology · 14d
Cleared Jul 31, 2003
RSV (RADIOLOGY SYSTEM VISIODENT
K031448 · EHD
Visiodent SA
Radiology · 85d
Cleared Jul 31, 2003
FILMLESS CLINIC
K031704 · LLZ
Connect Imaging, Inc.
Radiology · 59d
Cleared Jul 30, 2003
MR FIBER OPTIC ECG GATING SYSTEM
K031731 · LNH
Sa Instruments, Inc.
Radiology · 56d
Cleared Jul 30, 2003
DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
K031991 · KGI
Image Analysis, Inc.
Radiology · 33d
Cleared Jul 30, 2003
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · MOS
GE Medical Systems
Radiology · 28d
Cleared Jul 30, 2003
AURORA
K032082 · LNH
Aurora Imaging Technology, Inc.
Radiology · 23d
Cleared Jul 25, 2003
DPX SERIES BRAVO DUO BONE DENSITOMETER
K030962 · KGI
Ge Lunar Corp.
Radiology · 120d
Cleared Jul 25, 2003
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K031980 · HAW
Elekta Instrument AB
Radiology · 29d
Cleared Jul 25, 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · HAW
Elekta Instrument AB
Radiology · 28d
Cleared Jul 25, 2003
GE LOGIQ 7, MODEL 2354858
K032182 · IYN
General Electric Co.
Radiology · 8d
Cleared Jul 24, 2003
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
K032174 · LLZ
Wide Corporation
Radiology · 8d
Cleared Jul 23, 2003
SCANLUBE
K031222 · MUI
Sonotech, Inc.
Radiology · 97d
Cleared Jul 23, 2003
CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
K031920 · ITX
Trans Vascular Incorporated
Radiology · 30d
Cleared Jul 21, 2003
ENDOS DC
K030634 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 144d
Cleared Jul 21, 2003
DUNLEE FORMAT COLLIMATOR FAMILY
K031597 · IZW
Philips Medical Systems North America...
Radiology · 61d
Cleared Jul 21, 2003
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
K031638 · LLZ
Electromed Imaging, Inc.
Radiology · 55d
Cleared Jul 21, 2003
CORIX 70 PLUS-USV
K031802 · EHD
Coramex, S.A.
Radiology · 40d
Cleared Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Jul 21, 2003
SITE-RITE IV ULTRASOUND SYSTEM
K032135 · IYO
Dymax Corp
Radiology · 10d
Cleared Jul 18, 2003
PRIMA III TOTALSENSE TORSO COIL
K031365 · MOS
Usa Instruments, Inc.
Radiology · 79d