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
7729–7752 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 02, 2005
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV
K052348 · IYO
Volcano Corporation
Radiology · 95d
Cleared Nov 30, 2005
IMAGE STAR II
K052610 · JAA
Lakeshore Technologies, Inc.
Radiology · 69d
Cleared Nov 23, 2005
VISION (WITH OFF-LINE REVIEW)
K052391 · IYE
Varian Medical Systems
Radiology · 84d
Cleared Nov 23, 2005
SONOLINE G60 S ULTRASOUND SYSTEM
K052894 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Nov 23, 2005
VIMPLANT
K053155 · LLZ
Cybermed, Inc.
Radiology · 9d
Cleared Nov 22, 2005
VISTADENT AT COMPLETE, MODEL 3.1
K053010 · LLZ
Dentsply Intl., Inc.
Radiology · 27d
Cleared Nov 18, 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Nov 17, 2005
IMAGECAST PACS
K052618 · LLZ
Idx Systems Corp.
Radiology · 55d
Cleared Nov 17, 2005
CR-PRO
K052938 · MQB
Eradlink, Inc.
Radiology · 28d
Cleared Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · LNH
GE Medical Systems
Radiology · 22d
Cleared Nov 17, 2005
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K053042 · MOS
Medrad, Inc.
Radiology · 20d
Cleared Nov 16, 2005
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
K052537 · LLZ
American Medical Sales, Inc.
Radiology · 62d
Cleared Nov 16, 2005
COLOR NIO 2MP, E-2320 C
K052958 · LLZ
Barcoview
Radiology · 26d
Cleared Nov 16, 2005
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
K053017 · MOS
Invivo Corporation
Radiology · 21d
Cleared Nov 16, 2005
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K053069 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 16, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
K053084 · IYN
Kontron Medical Systems Sas
Radiology · 14d
Cleared Nov 14, 2005
SUPERDIMENSION/BRONCHUS PREMIUM
K052852 · JAK
Superdimension, Ltd.
Radiology · 34d
Cleared Nov 10, 2005
ACUSON CYPRESS ULTRASOUND SYSTEM
K052331 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Nov 09, 2005
SMIT SLEEVE
K052228 · JAQ
Nucletron Corporation
Radiology · 85d
Cleared Nov 09, 2005
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K052916 · MOS
Usa Instruments, Inc.
Radiology · 23d
Cleared Nov 09, 2005
GE 1.5T SIGNA HDE MR SYSTEM
K052978 · LNH
Ge Medical Systems, LLC
Radiology · 16d
Cleared Nov 08, 2005
INFINITT G3 PACS
K052545 · LLZ
Infinitt Co., Ltd.
Radiology · 54d
Cleared Nov 08, 2005
CRC 15ULTRA
K052595 · JAQ
Capintec, Inc.
Radiology · 48d
Cleared Nov 08, 2005
MODIFICATION TO: AURORA
K052698 · LNH
Aurora Imaging Technology, Inc.
Radiology · 41d