FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
10321–10344 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 14, 1998
SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING...
K974457 · IYO
Hewlett-Packard Co.
Radiology · 231d
Cleared Jul 14, 1998
XR-910
K981466 · IZL
Imaging Sciences Intl., Inc.
Radiology · 82d
Cleared Jul 14, 1998
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
K981475 · LNH
Toshiba America Mri, Inc.
Radiology · 81d
Cleared Jul 14, 1998
FLUOROSPOT COMPACT
K982028 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Jul 14, 1998
BIOPSY M
K982049 · IZH
Sitco, Inc.
Radiology · 33d
Cleared Jul 14, 1998
CAAS II LVA BIPLANE OPTION
K982203 · IZI
Pie Medical Equipment B.V.
Radiology · 22d
Cleared Jul 13, 1998
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402
K981352 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 90d
Cleared Jul 13, 1998
ARTOSCAN S
K981358 · LHN
Biosound Esaote, Inc.
Radiology · 90d
Cleared Jul 10, 1998
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM
K981346 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 87d
Cleared Jul 09, 1998
SEQUENCER
K981313 · IYE
Impac Medical Systems, Inc.
Radiology · 90d
Cleared Jul 06, 1998
ADVANTAGE 3D XR
K974715 · JAK
GE Medical Systems
Radiology · 201d
Cleared Jul 02, 1998
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL...
K973363 · IWI
Ml Strategies, Inc.
Radiology · 297d
Cleared Jun 30, 1998
HIGH IMPEDANCE CARDIAC GATING CABLE
K981190 · LNH
GE Medical Systems
Radiology · 89d
Cleared Jun 30, 1998
SYMPHONY 360 REMOTE CONTROL TABLE
K981227 · JAA
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jun 30, 1998
7200 ULTRASOUND IMAGING SYSTEM
K981293 · IYO
Biosound Esaote, Inc.
Radiology · 82d
Cleared Jun 30, 1998
HAMMERSMITH ENDOCAVITARY COILS
K981410 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 71d
Cleared Jun 29, 1998
RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
K965223 · IYO
Endosonics Corp.
Radiology · 545d
Cleared Jun 29, 1998
VANTAGE 3.0 INSYNCH
K981291 · KPS
Adac Laboratories
Radiology · 81d
Cleared Jun 26, 1998
PATHFINDER MOBILE C ARM
K981131 · OXO
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jun 25, 1998
RADIO-PLAST
K981115 · LHN
Smith & Nephew, Inc.
Radiology · 90d
Cleared Jun 19, 1998
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873 · LMA
Konica Corp.
Radiology · 105d
Cleared Jun 19, 1998
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
K981470 · IZH
Worldwide Medical Technologies, LLC
Radiology · 57d
Cleared Jun 18, 1998
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
K981053 · LMD
Eastman Kodak Company
Radiology · 87d
Cleared Jun 18, 1998
MEDRAD NEUROVASCULAR COIL
K981094 · MOS
Medrad, Inc.
Radiology · 84d