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
8593–8616 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 08, 2003
AUTOGEL PAD
K031018 · MUI
Rich-Mar Corp.
Radiology · 252d
Cleared Dec 04, 2003
SENO ADVANTAGE
K033400 · LLZ
Ge Medical Systems W-400
Radiology · 41d
Cleared Dec 03, 2003
ADVANTAGE PADDLE
K033202 · IZH
Livingston Products, Inc.
Radiology · 62d
Cleared Dec 02, 2003
XIO RADIATION TREATMENT PLANNING SYSTEM
K032762 · IYE
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Nov 26, 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · LLZ
Eastman Kodak Company
Radiology · 231d
Cleared Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
K031524 · JAQ
Varian Medical Systems, Inc.
Radiology · 195d
Cleared Nov 26, 2003
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
K033292 · MOS
Igc-Medical Advances, Inc.
Radiology · 43d
Cleared Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Nov 25, 2003
MDIFICATION TO MEDIPRIME
K033013 · LLZ
Algotec Systems, Ltd.
Radiology · 60d
Cleared Nov 25, 2003
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K033504 · LNH
General Electric Co.
Radiology · 20d
Cleared Nov 25, 2003
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K033567 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Nov 20, 2003
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
K033431 · KPS
Cti Pet Systems, Inc.
Radiology · 23d
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502 · JAK
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 19, 2003
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345 · KPR
Analogic Corp.
Radiology · 30d
Cleared Nov 19, 2003
GE PRECISION MPI
K033486 · OWB
Nrt-Nordisk Rontgen Teknik A/S
Radiology · 15d
Cleared Nov 14, 2003
MOBILETTE XP AND MOBILETT XPHYBRID
K033238 · IZL
Siemens Medical Systems, Inc.
Radiology · 39d
Cleared Nov 14, 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K033353 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Nov 12, 2003
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
K033066 · OXO
Xitec Holdings, LLC
Radiology · 44d
Cleared Nov 12, 2003
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
K033199 · KPS
Is2 Medical Systems, Inc.
Radiology · 41d
Cleared Nov 12, 2003
MODIFICATION TO: HI-ART SYSTEM
K033347 · IYE
Tomotherapy Incorporated
Radiology · 23d
Cleared Nov 10, 2003
ANZAI AZ-733 RESPIRATORY GATING SYSTEM
K031385 · LHN
Anzai Medical Co., Ltd.
Radiology · 193d
Cleared Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 10, 2003
MEDICHEART, MODEL RELEASE 1
K032823 · JAK
Medicsight
Radiology · 61d