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
10009–10032 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 30, 1999
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
K991546 · IYE
Aktina Medical Physics Corp.
Radiology · 88d
Cleared Jul 30, 1999
ULTRASOUND SCANNER, MODEL TYPE 2101
K991937 · IYO
B & K Medical A/S
Radiology · 51d
Cleared Jul 30, 1999
MAMEX
K992037 · IZH
Del Medical Imaging Corp.
Radiology · 44d
Cleared Jul 26, 1999
VANTAGE 2.5
K991607 · KPS
Adac Laboratories
Radiology · 77d
Cleared Jul 20, 1999
AWARE PAD
K991469 · IYO
Aac Consulting Group, Inc.
Radiology · 83d
Cleared Jul 19, 1999
MR SPECTROSCOPY PACKAGE
K991568 · LNI
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared Jul 14, 1999
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
K983660 · LHN
Brainlab, Inc.
Radiology · 268d
Cleared Jul 14, 1999
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K984563 · IWB
Accuray, Inc.
Radiology · 203d
Cleared Jul 12, 1999
THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
K984639 · ITX
Medison America, Inc.
Radiology · 193d
Cleared Jul 12, 1999
BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY
K991336 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 84d
Cleared Jul 12, 1999
GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
K992208 · IYO
Ge Medical Systems, Inc.
Radiology · 12d
Cleared Jul 08, 1999
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL...
K992155 · ITX
Medison America, Inc.
Radiology · 13d
Cleared Jul 06, 1999
QUADRATURE WRIST COIL, MODEL 445PH-64
K991434 · MOS
Medical Advances, Inc.
Radiology · 71d
Cleared Jul 06, 1999
IMMERGE IMAGE CORRELATION
K991468 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 70d
Cleared Jul 06, 1999
SAMSUNG RAYPAX SYSTEM
K991537 · LMD
Samsung Sds Co., Ltd.
Radiology · 64d
Cleared Jul 02, 1999
MODIFICATION TO GAMMA GUIDANCE SYSTEM
K983768 · IZD
Radiation Monitoring Devices, Inc.
Radiology · 249d
Cleared Jul 02, 1999
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
K991626 · LLZ
Analogic Corp.
Radiology · 52d
Cleared Jun 30, 1999
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
K991282 · LMC
Seiko Instruments USA, Inc.
Radiology · 77d
Cleared Jun 29, 1999
AMIB7
K990198 · IYO
Alliance Medical, Inc.
Radiology · 159d