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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
10993–11016 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 28, 1996
GAMMACON IMAGE TRANSLATION SYSTEM
K962955 · KPS
Medical Imaging Technology Assoc., Inc.
Radiology · 90d
Cleared Oct 28, 1996
FUJI MEDICAL DRY IMAGER FM-DP 2636
K962967 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Oct 25, 1996
CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE
K951567 · ITX
Cardio Metrics, Inc.
Radiology · 570d
Cleared Oct 25, 1996
SLS-CT
K960985 · JAK
Bio-Imaging Research, Inc.
Radiology · 239d
Cleared Oct 25, 1996
VIEWSEND MEDICAL MODEL 1200
K962225 · LMD
Klt Telecom, Inc.
Radiology · 137d
Cleared Oct 25, 1996
OPART MRT-600
K962933 · LNH
Toshiba America Mri, Inc.
Radiology · 88d
Cleared Oct 25, 1996
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
K963395 · LMB
Sectra-Imtec AB
Radiology · 58d
Cleared Oct 18, 1996
FLEXART TMJ COIL
K961624 · LNH
Toshiba America Mri, Inc.
Radiology · 175d
Cleared Oct 18, 1996
ADVANTAGE WINDOWS TISSUE VOLUME OPTION
K963345 · LNH
GE Medical Systems
Radiology · 53d
Cleared Oct 15, 1996
ECAT EXACT & ECAT EXACT HR+
K962797 · KPS
Cti Pet Systems, Inc.
Radiology · 89d
Cleared Oct 10, 1996
MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
K962738 · KPS
GE Medical Systems
Radiology · 87d
Cleared Oct 02, 1996
ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER
K963185 · EHD
Electronic Control Concepts
Radiology · 49d
Cleared Oct 01, 1996
INTRA-ORAL THERMOPLASTIC SHIELD
K962622 · KPY
Medtec, Inc.
Radiology · 88d
Cleared Oct 01, 1996
BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000
K963585 · IYO
Diagnostic Ultrasound Corp.
Radiology · 22d
Cleared Sep 27, 1996
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
K962613 · JAD
Gulmay Medical , Ltd.
Radiology · 86d
Cleared Sep 27, 1996
PATRIOT
K963037 · LLZ
Infimed, Inc.
Radiology · 53d
Cleared Sep 25, 1996
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
K962927 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Sep 23, 1996
DIGIPAN
K961826 · EHD
Trophy Radiologie
Radiology · 133d
Cleared Sep 20, 1996
STEP OPTION TO PRISM 2000
K960865 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 200d
Cleared Sep 20, 1996
FLUOROPLUS CARDIAC TV
K961140 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 183d
Cleared Sep 20, 1996
AURORA DIAGNOSTIC WORKSTATION
K962589 · LLZ
Aurora Technology, Inc.
Radiology · 80d
Cleared Sep 20, 1996
ESTEEM 1.5T MRI SYSTEM
K962677 · LNH
Elscint Mr, Inc.
Radiology · 73d
Cleared Sep 20, 1996
KODAK DIGITAL SCIENCE REMOTE CASSETTE
K962896 · KPR
Eastman Kodak Company
Radiology · 57d
Cleared Sep 16, 1996
OLYMPUS MH-246R BALLOON SHEATH
K961048 · ODG
Olympus America, Inc.
Radiology · 185d