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
9985–10008 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 23, 1999
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE,...
K990241 · LLZ
Accuimage Diagnostics Corp.
Radiology · 241d
Cleared Sep 23, 1999
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577 · JAD
Photoelectron Corporation
Radiology · 52d
Cleared Sep 22, 1999
SAMSUNG RAYPAX DISPLAY WORKSTATION
K992306 · LLZ
Samsung Sds Co., Ltd.
Radiology · 75d
Cleared Sep 22, 1999
GE DIASONICS GATEWAY AND GATEWAY FX
K993069 · IYO
General Electric Co.
Radiology · 9d
Cleared Sep 21, 1999
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
K991319 · IYE
Orfit Industries
Radiology · 155d
Cleared Sep 21, 1999
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K992963 · KXK
International Isotopes, Inc.
Radiology · 19d
Cleared Sep 16, 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
K992892 · LNH
Magnetic Moments, LLC
Radiology · 20d
Cleared Sep 13, 1999
SAMSUNG RAYPAX LONG TERM ARCHIVE
K992131 · LMB
Samsung Sds Co., Ltd.
Radiology · 82d
Cleared Sep 09, 1999
PHILIPS EASYVISION WORKSTATION:
K990335 · LNH
Philips Medical Systems North...
Radiology · 218d
Cleared Sep 09, 1999
AX WORKSTATION
K992073 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Sep 09, 1999
SAMSUNG RAYPAX FILM DIGITIZER
K992112 · LLZ
Samsung Sds Co., Ltd.
Radiology · 79d
Cleared Sep 09, 1999
RENDER-PLAN 3-D
K992864 · MUJ
Precision Therapy Intl., Inc.
Radiology · 15d
Cleared Sep 08, 1999
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
K992135 · LNH
Ge Medical Systems, Inc.
Radiology · 76d
Cleared Sep 08, 1999
ECHOCARDIOGRAPHY SYSTEM SERIES 95000
K992259 · LLZ
Camtronics, Ltd.
Radiology · 64d
Cleared Sep 08, 1999
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
K992305 · ITX
Medi-Stim A/S
Radiology · 62d
Cleared Sep 07, 1999
QUANTITATIVE FLOW
K992225 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 67d
Cleared Sep 07, 1999
GENDEX 765DC, MODEL 110-0154
K992610 · EHD
Dentsply Intl.
Radiology · 34d
Cleared Sep 03, 1999
THE NOMOS CHANE II
K991966 · IYE
Nomos Corp.
Radiology · 85d
Cleared Sep 03, 1999
ENDO-ESOPHAGEAL MR COIL
K992193 · MOS
Surgi-Vision, Inc.
Radiology · 66d
Cleared Sep 03, 1999
QCT BONE MINERAL ANALYSIS SOFTWARE
K992246 · KGI
Image Analysis, Inc.
Radiology · 59d
Cleared Sep 03, 1999
LORAD 1-650 (INTERNATIONAL 650)
K992280 · IZH
Lorad Corp.
Radiology · 58d
Cleared Sep 03, 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
K992677 · KGI
Hologic, Inc.
Radiology · 24d
Cleared Sep 03, 1999
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753 · MUJ
Varian Assoc., Inc.
Radiology · 18d
Cleared Sep 03, 1999
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
K992896 · EGY
Dental X-Ray Support Systems, Inc.
Radiology · 7d