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
9697–9720 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 13, 2000
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
K002003 · IYN
Atl Ultrasound, Inc.
Radiology · 13d
Cleared Jul 13, 2000
POCKET ULTRASONIC PACHYMETER
K993674 · IYO
Quantel Medical
Radiology · 255d
Cleared Jul 13, 2000
BRAINSCAN
K994413 · MUJ
Brainlab AG
Radiology · 197d
Cleared Jul 10, 2000
PEDIATRIC REFERENCE DATA
K001812 · KGI
Lunar Corp.
Radiology · 25d
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Jul 06, 2000
LIFERX
K001596 · LLZ
Bowdengs Technologies, LLC
Radiology · 44d
Cleared Jul 06, 2000
LUNAR REPORT GENERATOR II
K001756 · KGI
Lunar Corp.
Radiology · 27d
Cleared Jul 06, 2000
MODIFICATION TO E-SCAN
K001894 · LNH
Biosound Esaote, Inc.
Radiology · 15d
Cleared Jun 30, 2000
VSCORE WITH EKG SIGNAL GATING
K001682 · JAK
Vital Images, Inc.
Radiology · 29d
Cleared Jun 30, 2000
UNICORN MODEL SYS0630
K001888 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Jun 29, 2000
NICOLET EME LEGEND TC22
K993939 · IYN
Nicolet Biomedical
Radiology · 223d
Cleared Jun 28, 2000
XPLAN 2.1
K001700 · MUJ
Radionics, Inc.
Radiology · 23d
Cleared Jun 27, 2000
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · IZL
Shimadzu Corp.
Radiology · 42d
Cleared Jun 23, 2000
VARIS 1.4G
K001643 · IYE
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jun 22, 2000
ULTRASIM CT SYSTEM
K001088 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 79d
Cleared Jun 22, 2000
ORTHOCEPH OC100 D
K001439 · MUH
Instrumentarium Corp.
Radiology · 45d
Cleared Jun 22, 2000
NOVAC7
K990209 · IYE
Hitesys S.P.A.
Radiology · 518d
Cleared Jun 20, 2000
3D-MSPECT
K001026 · KPS
The Reagents of the University of...
Radiology · 82d
Cleared Jun 20, 2000
BREAST IMMOBILIZATION DEVICE MR-BY 160
K001303 · MOS
Mri Devices Corp.
Radiology · 57d
Cleared Jun 20, 2000
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
K001312 · MOS
Igc-Medical Advances, Inc.
Radiology · 55d
Cleared Jun 20, 2000
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
K001711 · IYN
Agilent Technologies, Inc.
Radiology · 15d
Cleared Jun 20, 2000
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
K993176 · KGI
Norland Medical Systems, Inc.
Radiology · 272d
Cleared Jun 14, 2000
HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
K001713 · MOS
Mri Devices Corp.
Radiology · 9d
Cleared Jun 13, 2000
DIGITAL INTEGRATION SYSTEM, DIS2000
K001012 · LLZ
Wellington Medical Systems, Inc.
Radiology · 76d