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
9745–9768 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 09, 2000
HI-RES 9000 PHASED ARRAY CAROTID COIL
K001210 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Jun 09, 2000
SYNERGY HEAD/NECK COIL
K001331 · MOS
Philips Medical Systems North...
Radiology · 43d
Cleared Jun 09, 2000
PHARMASEED, MODEL BT-125-2
K993701 · KXK
Syncor International, Inc.
Radiology · 220d
Cleared Jun 08, 2000
AU5 ULTRASOUND IMAGING SYSTEM
K000931 · IYN
Biosound Esaote, Inc.
Radiology · 78d
Cleared Jun 02, 2000
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K001336 · KPR
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
DR5000 DEDICATED CHEST X-RAY SYSTEM
K001341 · KPR
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
XPLORER 1000
K992955 · MQB
Imaging Dynamics Corp.
Radiology · 275d
Cleared Jun 02, 2000
PHARMASEED, MODEL BT-103-2
K993700 · KXK
Syncor International, Inc.
Radiology · 213d
Cleared Jun 02, 2000
OPTIRAD
K993895 · MUJ
Permedics, Inc.
Radiology · 199d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994069 · ITX
Olympus America, Inc.
Radiology · 183d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994106 · ITX
Olympus America, Inc.
Radiology · 179d
Cleared Jun 01, 2000
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976 · IZH
Instrumentarium Imaging, Inc.
Radiology · 66d
Cleared Jun 01, 2000
VFSS IMAGER, MODEL SIS-300
K000987 · JAA
Lifecare Imaging Intl., Ltd.
Radiology · 66d
Cleared Jun 01, 2000
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
K001201 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jun 01, 2000
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
K001209 · MOS
Usa Instruments, Inc.
Radiology · 48d
Cleared May 26, 2000
SPIRAL IMAGING OPTION
K000802 · LNH
GE Medical Systems
Radiology · 74d
Cleared May 26, 2000
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
K000960 · IYO
Barzell-Whitmore Maroon Bells, Inc.
Radiology · 63d