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
8473–8496 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 29, 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · LLZ
Vital Images, Inc.
Radiology · 54d
Cleared Oct 29, 2003
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
K033088 · LLZ
Sectra AB
Radiology · 30d
Cleared Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 29, 2003
SUPEROPEN 0.23T, MODEL NAM-P023A
K033315 · LNH
Neusoft Digital Medical Systems Co.,...
Radiology · 14d
Cleared Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · JAK
Philips Medical Systems, Inc.
Radiology · 13d
Cleared Oct 23, 2003
BIOPSY BREAST COIL, MODEL BBC
K032576 · MOS
Mri Devices Corp.
Radiology · 64d
Cleared Oct 23, 2003
ELEKTA SYNERGY SYSTEM
K032996 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 28d
Cleared Oct 23, 2003
GE MARLIN ULTRASOUND
K033139 · IYN
General Electric Co.
Radiology · 23d
Cleared Oct 22, 2003
GE LOGIQ BOOK
K032477 · IYN
General Electric Co.
Radiology · 71d
Cleared Oct 22, 2003
FORTE GAMMA CAMERA SYSTEM
K033254 · KPS
Adac Laboratories
Radiology · 14d
Cleared Oct 21, 2003
GE LOGIQ 5 PRO OR EXPERT
K032974 · IYN
General Electric Co.
Radiology · 27d
Cleared Oct 20, 2003
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
K033248 · MUH
Hitachi Medical Systems America, Inc.
Radiology · 13d
Cleared Oct 17, 2003
VIEWMATE ULTRASOUND IMAGING SYSTEM
K031066 · IYN
Ep Medsystems
Radiology · 197d
Cleared Oct 16, 2003
MAGNETOM AVANTO MR SYSTEM
K032428 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Oct 16, 2003
PROWESS
K032456 · MUJ
Prowess, Inc.
Radiology · 66d
Cleared Oct 16, 2003
INTELEPACS
K032533 · LLZ
Intelerad Medical Systems, Inc.
Radiology · 62d
Cleared Oct 16, 2003
HOLOGIC DR IMAGEPRO
K032546 · LLZ
Hologic, Inc.
Radiology · 59d
Cleared Oct 16, 2003
SONOLINE ANTARES WITH CLARIFY VE
K033196 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · OWB
Ge Medical Systems, Inc.
Radiology · 9d
Cleared Oct 14, 2003
AUTOALIGN
K032186 · LLZ
Cortechs Labs, Inc.
Radiology · 89d
Cleared Oct 10, 2003
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
K032471 · LHQ
Titronics Research & Development Co.
Radiology · 60d
Cleared Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
K032620 · IYN
General Electric Co.
Radiology · 45d
Cleared Oct 10, 2003
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
K032924 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 18d
Cleared Oct 10, 2003
ACCUSONIC A-SCAN MODEL, 24-4000
K032956 · IYO
Accutome, Inc.
Radiology · 18d