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
9097–9120 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 03, 2002
LIGHT SABER SPINAL NEEDLE
K021084 · FMF
Minrad, Inc.
Radiology · 90d
Cleared Jul 02, 2002
CRANIAL STEREOTACTIC EQUIPMENT
K010065 · IYE
Arplay Medical S.A.
Radiology · 540d
Cleared Jul 02, 2002
RE-ENTRANT CHAMBER
K013689 · KPT
Sun Nuclear Corp.
Radiology · 238d
Cleared Jul 02, 2002
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
K021124 · IYE
Wfr/Aquaplast Corp.
Radiology · 85d
Cleared Jul 02, 2002
SCEPTRE-VS
K021314 · LLZ
Hitachi Medical Systems America, Inc.
Radiology · 68d
Cleared Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829 · MQB
Eastman Kodak Company
Radiology · 28d
Cleared Jul 02, 2002
Q LAB SOFTWARE
K021966 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 15d
Cleared Jul 02, 2002
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM
K021984 · IYN
Inceptio Medical Technologies, LC
Radiology · 14d
Cleared Jun 27, 2002
REX, VERSION 1.0
K021099 · LLZ
Pointdx, Inc.
Radiology · 84d
Cleared Jun 27, 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141 · MOS
Usa Instruments, Inc.
Radiology · 79d
Cleared Jun 21, 2002
CINESCAN S
K021683 · IYO
Quantel Medical
Radiology · 30d
Cleared Jun 19, 2002
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC...
K021886 · FDS
Olympus Optical Co., Ltd.
Radiology · 12d
Cleared Jun 17, 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
K021016 · IZL
GE Medical Systems
Radiology · 80d
Cleared Jun 17, 2002
CARDIOSPECT D90/CARDIO CAM
K021823 · KPS
Nuclear Cardiology Systems, Inc.
Radiology · 13d
Cleared Jun 13, 2002
X-IMAGE DIGITAL X-RAY SYSTEM
K020588 · MUH
Escape Technology, Inc.
Radiology · 111d
Cleared Jun 13, 2002
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
K020630 · IYN
Ultrasonix Medical Corporation
Radiology · 107d
Cleared Jun 13, 2002
SYNGO MR 2002B
K020991 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Jun 13, 2002
MAMMOPATH
K021113 · MWP
Fischer Imaging Corp.
Radiology · 69d
Cleared Jun 13, 2002
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL
K021433 · MOS
Medical Advances, Inc.
Radiology · 38d
Cleared Jun 13, 2002
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
K021656 · KPS
Nuclear Diagnostics
Radiology · 24d
Cleared Jun 12, 2002
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K021570 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 12, 2002
OBC-127 BREAST ARRAY COIL
K021575 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 07, 2002
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
K020783 · LHQ
Telesis Technologies, Inc.
Radiology · 88d
Cleared Jun 07, 2002
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY
K021372 · EAG
J. Morita USA, Inc.
Radiology · 38d