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
9073–9096 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 12, 2002
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR...
K022292 · LLZ
Agfa Corp.
Radiology · 59d
Cleared Sep 12, 2002
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · KPS
General Electric Co.
Radiology · 14d
Cleared Sep 06, 2002
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · ODG
Pentax Precision Instrument Corp.
Radiology · 137d
Cleared Sep 06, 2002
CALSCOR SOFTWARE
K021913 · LLZ
3D Med Co., Ltd.
Radiology · 87d
Cleared Sep 06, 2002
KUSKE BREAST APPLICATOR SET, MODEL 189.006
K022635 · JAQ
Nucletron Corporation
Radiology · 29d
Cleared Sep 06, 2002
COOK-SWARTZ DOPPLER FLOW PROBE
K022649 · ITX
Cook Vascular, Inc.
Radiology · 28d
Cleared Sep 06, 2002
LR DICOM CONTROLLER
K022658 · LMC
Agfa Corp.
Radiology · 28d
Cleared Sep 06, 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669 · MOS
GE Medical Systems
Radiology · 25d
Cleared Sep 06, 2002
CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
K022720 · MOS
Mri Devices Corp.
Radiology · 22d
Cleared Sep 06, 2002
VIATRONIX V3D EXPLORER
K022789 · LLZ
Viatronix, Inc.
Radiology · 15d
Cleared Sep 06, 2002
SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K022858 · IYN
Novasonics, Inc.
Radiology · 9d
Cleared Sep 04, 2002
HRW-63-INT WRIST ARRAY COIL
K022588 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Aug 28, 2002
RADIOSYSTEM/NT, MODEL 80-13020
K020320 · IYE
Styker Instruments
Radiology · 209d
Cleared Aug 28, 2002
RF TENT
K022157 · LNH
Odin Medical Technologies , Ltd.
Radiology · 57d
Cleared Aug 23, 2002
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
K022239 · JAK
Praxim
Radiology · 43d
Cleared Aug 23, 2002
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K022487 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Aug 23, 2002
MODEL OBC-63 BREAST ARRAY COIL
K022488 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Aug 22, 2002
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
K022397 · LNH
GE Medical Systems
Radiology · 30d
Cleared Aug 19, 2002
FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES
K021738 · LLZ
Totoku Electric Co., Ltd.
Radiology · 83d
Cleared Aug 15, 2002
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
K021718 · MUH
Suni Imaging Microsystems, Inc.
Radiology · 84d
Cleared Aug 15, 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 79d
Cleared Aug 15, 2002
BLADDERSCAN BVI 6100
K022153 · IYO
Diagnostic Ultrasound Corp.
Radiology · 44d
Cleared Aug 14, 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · KPS
Cti Pet Systems, Inc.
Radiology · 89d
Cleared Aug 14, 2002
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K022270 · ODA
Olympus Optical Co., Ltd.
Radiology · 30d