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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
9889–9912 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 23, 1999
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
K992470 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 28d
Cleared Aug 23, 1999
SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
K992644 · MUH
Sirona Dental Systems GmbH
Radiology · 17d
Cleared Aug 19, 1999
MINI 6800 DIGITAL MOBILE C-ARM
K992506 · OXO
Ge Dec Medical Systems
Radiology · 23d
Cleared Aug 17, 1999
KONICA DIRECT DIGITIZER, MODEL DD-341
K990359 · MQB
Konica Corp.
Radiology · 193d
Cleared Aug 17, 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Aug 17, 1999
GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE...
K992152 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 53d
Cleared Aug 17, 1999
IPASS BOLUS TRACKING
K992412 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 28d
Cleared Aug 13, 1999
DIGITAL VIDEO RECORDING SYSTEM
K991738 · LLZ
Kay Elemetrics Corp.
Radiology · 84d
Cleared Aug 13, 1999
EXPLORER 3D
K991815 · MUJ
Our Scientific Intl., Inc.
Radiology · 78d
Cleared Aug 13, 1999
SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
K992046 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Aug 13, 1999
DYNAWELL OR DYNAWELL
K992120 · LNH
Ekeroth Quality AB
Radiology · 51d
Cleared Aug 10, 1999
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
K991766 · JAK
Toshiba America Medical Systems, In.C
Radiology · 78d
Cleared Aug 10, 1999
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826 · IZH
Planmed OY
Radiology · 74d
Cleared Aug 09, 1999
CADPLAN HELIOS OPTION 6.0
K984532 · MUJ
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Aug 06, 1999
MXU-125 OR TMX-125
K992229 · IZL
Trex Medical Corp.
Radiology · 35d
Cleared Aug 03, 1999
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K991652 · LNH
Siemens Corp.
Radiology · 82d
Cleared Aug 02, 1999
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND...
K991565 · KPS
Smv America
Radiology · 89d
Cleared Aug 02, 1999
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED...
K991629 · LLZ
Ge Medical Systems, Inc.
Radiology · 83d
Cleared Aug 02, 1999
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
K991724 · MOS
Medical Advances, Inc.
Radiology · 74d
Cleared Aug 02, 1999
OPART, MODEL MRT-600
K991740 · MOS
Toshiba America Mri, Inc.
Radiology · 73d
Cleared Aug 02, 1999
SYNERGY SHOULDER COIL
K991765 · MOS
Philips Medical Systems North...
Radiology · 70d
Cleared Aug 02, 1999
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
K991805 · IYN
Acuson Corp.
Radiology · 68d
Cleared Jul 30, 1999
TLC PEDIATRIC FRAME, MODEL TLC-SYS
K991523 · IYE
Radionics, Inc.
Radiology · 88d
Cleared Jul 30, 1999
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991535 · KPS
Hitachi Medical Corp. of America
Radiology · 88d