FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
8569–8592 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158 · JAQ
Nucletron Corp.
Radiology · 118d
Cleared Aug 07, 2003
OTP 1.2
K031349 · MUJ
Nucletron Corp.
Radiology · 100d
Cleared Aug 07, 2003
PRACTICEBUILDER 1-2-3
K031778 · LLZ
Erad Imagemedical Corp.
Radiology · 58d
Cleared Aug 06, 2003
CADSTREAM
K031779 · LLZ
Confirma, Inc.
Radiology · 57d
Cleared Aug 06, 2003
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K032281 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
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