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
9193–9216 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 05, 2001
MHS 5000
K011981 · LHQ
Micro Health Systems, Inc.
Radiology · 72d
Cleared Sep 04, 2001
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · KXK
Cp Medical
Radiology · 187d
Cleared Aug 31, 2001
MBI PD-103 SL
K011427 · KXK
Mills Biopharmaceuticals, Inc.
Radiology · 115d
Cleared Aug 31, 2001
INTERCEPT-URETHRAL MICROCOIL
K011781 · MOS
Surgi-Vision, Inc.
Radiology · 85d
Cleared Aug 31, 2001
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
K012663 · IZL
Sedecal USA, Inc.
Radiology · 18d
Cleared Aug 30, 2001
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
K012253 · IYO
Aloka Co., Ltd.
Radiology · 43d
Cleared Aug 29, 2001
VIEWSTATION
K011694 · LLZ
Impac Medical Systems, Inc.
Radiology · 90d
Cleared Aug 29, 2001
ELK LASER IMAGER, MODEL EL-DRY 4000
K011949 · LMC
Nishimoto Sangyo Co., Ltd.
Radiology · 69d
Cleared Aug 29, 2001
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
K012080 · IYN
Aloka Co., Ltd.
Radiology · 57d
Cleared Aug 29, 2001
E-SCAN MRI SYSTEM
K012728 · MOS
Biosound Esaote, Inc.
Radiology · 14d
Cleared Aug 27, 2001
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 90d
Cleared Aug 27, 2001
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC...
K011886 · ODG
Olympus America, Inc.
Radiology · 73d
Cleared Aug 23, 2001
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
K010772 · JAA
Imaging Services, Inc.
Radiology · 162d
Cleared Aug 23, 2001
GE LOGIQ A100 MP, MODEL 2272413
K012560 · IYO
General Electric Co.
Radiology · 15d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604 · LNI
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Aug 16, 2001
PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
K012379 · IZL
Trex Enterprises Corp.
Radiology · 21d
Cleared Aug 14, 2001
MODEL 235GE-64
K011608 · MOS
Medical Advances, Inc.
Radiology · 81d
Cleared Aug 14, 2001
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
K012289 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 25d
Cleared Aug 14, 2001
HNC-127 NEUROVASCULAR ARRAY COIL
K012353 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Aug 10, 2001
CYBERKNIFE SYSTEM
K011024 · IYE
Accuray, Inc.
Radiology · 128d
Cleared Aug 10, 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · LLZ
Eastman Kodak Company
Radiology · 30d
Cleared Aug 10, 2001
DIGORA PCT
K012170 · MUH
Soredex Palodex Group OY
Radiology · 29d
Cleared Aug 10, 2001
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER
K012239 · IYN
Hitachi Medical Corp.
Radiology · 24d
Cleared Aug 10, 2001
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
K012369 · IYN
Atys Medical
Radiology · 15d