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
8641–8664 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 17, 2003
VIEWMATE ULTRASOUND IMAGING SYSTEM
K031066 · IYN
Ep Medsystems
Radiology · 197d
Cleared Oct 16, 2003
MAGNETOM AVANTO MR SYSTEM
K032428 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Oct 16, 2003
PROWESS
K032456 · MUJ
Prowess, Inc.
Radiology · 66d
Cleared Oct 16, 2003
INTELEPACS
K032533 · LLZ
Intelerad Medical Systems, Inc.
Radiology · 62d
Cleared Oct 16, 2003
HOLOGIC DR IMAGEPRO
K032546 · LLZ
Hologic, Inc.
Radiology · 59d
Cleared Oct 16, 2003
SONOLINE ANTARES WITH CLARIFY VE
K033196 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · OWB
Ge Medical Systems, Inc.
Radiology · 9d
Cleared Oct 14, 2003
AUTOALIGN
K032186 · LLZ
Cortechs Labs, Inc.
Radiology · 89d
Cleared Oct 10, 2003
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
K032471 · LHQ
Titronics Research & Development Co.
Radiology · 60d
Cleared Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
K032620 · IYN
General Electric Co.
Radiology · 45d
Cleared Oct 10, 2003
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
K032924 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 18d
Cleared Oct 10, 2003
ACCUSONIC A-SCAN MODEL, 24-4000
K032956 · IYO
Accutome, Inc.
Radiology · 18d
Cleared Oct 10, 2003
ORTHOPHOS XG DS/CEPH
K033073 · EHD
Sirona Dental Systems GmbH
Radiology · 11d
Cleared Oct 10, 2003
KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL
K033151 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
HAC-12 AND HAC-30 HEAD ARRAY COIL
K033152 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Oct 10, 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
K033168 · LNH
General Electric Co.
Radiology · 10d
Cleared Oct 09, 2003
PORT CASSETTE
K032654 · IXK
Orex Computed Radiography, Ltd.
Radiology · 42d
Cleared Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · MUJ
Adac Laboratories
Radiology · 36d
Cleared Oct 08, 2003
GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
K032795 · LNH
Ge Medical Systems, LLC
Radiology · 30d
Cleared Oct 08, 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
K032960 · LLZ
Wide Corporation
Radiology · 15d
Cleared Oct 03, 2003
MOSFET AUTOSENSE WIRELESS
K032725 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 30d
Cleared Oct 02, 2003
3D INVIVO BY CSIST
K031567 · LLZ
Chung-Shan Institute of Science and...
Radiology · 136d
Cleared Oct 02, 2003
SECTRA ORTHOPEDIC PACKAGE
K031590 · LLZ
Sectra-Imtec AB
Radiology · 134d
Cleared Oct 02, 2003
I-BEAM
K032100 · IYE
Computerized Medical Systems, Inc.
Radiology · 86d