FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
8929–8952 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 25, 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330 · MOS
Usa Instruments, Inc.
Radiology · 90d
Cleared Jul 17, 2002
SURGERY AND ACCESSORIES
K021236 · LLZ
Camtronics, Ltd.
Radiology · 90d
Cleared Jul 16, 2002
LUNGCARE CT SOFTWARE PACKAGE
K022013 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Jul 13, 2002
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311 · KXK
Cp Medical
Radiology · 79d
Cleared Jul 12, 2002
MEDICAL ADMINISTRATOR
K020073 · LLZ
Barco N.V.
Radiology · 184d
Cleared Jul 12, 2002
AUTOALIGN
K021191 · LLZ
Cortechs Labs, Inc.
Radiology · 88d
Cleared Jul 12, 2002
MPOWER, MODEL 712 SERIES
K022001 · KPS
Positron Corp.
Radiology · 23d
Cleared Jul 12, 2002
EIZO, MODEL FC-2091
K022109 · LLZ
Eizo Nanao Corporation
Radiology · 14d
Cleared Jul 10, 2002
ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
K020668 · IYO
Aloka Co., Ltd.
Radiology · 131d
Cleared Jul 10, 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · IXA
Eastman Kodak Company
Radiology · 30d
Cleared Jul 09, 2002
CYPRESS ULTRASOUND SYSTEM
K021497 · IYN
Acuson Corp.
Radiology · 61d
Cleared Jul 09, 2002
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION...
K022050 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
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