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
8425–8448 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 17, 2003
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL
K033235 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Dec 17, 2003
MEDICAL IMAGE DIGITIZER, MODEL 2908
K033637 · LMA
Array Corp.
Radiology · 28d
Cleared Dec 17, 2003
PELVIC ARRAY COIL
K033753 · MOS
Usa Instruments, Inc.
Radiology · 16d
Cleared Dec 15, 2003
ACCUSOFT
K032171 · IYE
Direx Systems Corp.
Radiology · 152d
Cleared Dec 15, 2003
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
K033604 · IYO
Pie Medical
Radiology · 28d
Cleared Dec 15, 2003
PACS SOFTWARE SOLUTION 2003
K033624 · LLZ
Canon USA, Inc.
Radiology · 27d
Cleared Dec 12, 2003
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · DXC
Vascular Control Systems, Inc.
Radiology · 183d
Cleared Dec 12, 2003
CLARITY PET
K032866 · KPS
Shared P.E.T. Imaging, LLC
Radiology · 88d
Cleared Dec 12, 2003
VANTAGE PRO ATTENUATION CORRECTION DEVICE
K033735 · KPS
Adac Laboratories
Radiology · 14d
Cleared Dec 09, 2003
OB1 OBSTETRICAL DOPPLER
K033156 · KNG
D. E. Hokanson, Inc.
Radiology · 70d
Cleared Dec 09, 2003
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
K033184 · IZI
Shimadzu Corp.
Radiology · 69d
Cleared Dec 09, 2003
ALLURA XPER FD20
K033737 · OWB
Philips Medical Systems North...
Radiology · 11d
Cleared Dec 08, 2003
AUTOGEL PAD
K031018 · MUI
Rich-Mar Corp.
Radiology · 252d
Cleared Dec 04, 2003
SENO ADVANTAGE
K033400 · LLZ
Ge Medical Systems W-400
Radiology · 41d
Cleared Dec 03, 2003
ADVANTAGE PADDLE
K033202 · IZH
Livingston Products, Inc.
Radiology · 62d
Cleared Dec 02, 2003
XIO RADIATION TREATMENT PLANNING SYSTEM
K032762 · IYE
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Nov 26, 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · LLZ
Eastman Kodak Company
Radiology · 231d
Cleared Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
K031524 · JAQ
Varian Medical Systems, Inc.
Radiology · 195d
Cleared Nov 26, 2003
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
K033292 · MOS
Igc-Medical Advances, Inc.
Radiology · 43d
Cleared Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Nov 25, 2003
MDIFICATION TO MEDIPRIME
K033013 · LLZ
Algotec Systems, Ltd.
Radiology · 60d
Cleared Nov 25, 2003
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K033504 · LNH
General Electric Co.
Radiology · 20d
Cleared Nov 25, 2003
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K033567 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Nov 20, 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
K033431 · KPS
Cti Pet Systems, Inc.
Radiology · 23d