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
9265–9288 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 06, 2001
QED DIODE DETECTORS, MODELS 1112-1116
K011466 · LNH
Sun Nuclear Corp.
Radiology · 23d
Cleared Jun 06, 2001
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER
K011485 · LNH
Fonar Corp.
Radiology · 22d
Cleared Jun 05, 2001
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K010682 · MUJ
Mds Nordion
Radiology · 90d
Cleared May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · MOS
Usa Instruments, Inc.
Radiology · 62d
Cleared May 30, 2001
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
K011111 · KPR
Modular X-Ray Devices
Radiology · 49d
Cleared May 30, 2001
EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM
K011252 · IYO
Hitachi Medical Corp.
Radiology · 36d
Cleared May 30, 2001
PROGNOST ES, MODEL 0302 0000
K011290 · IZF
Xmar Corp.
Radiology · 33d
Cleared May 25, 2001
KFA-127 KNEE, FOOT AND ANKLE ARRAY
K003505 · MOS
Mri Devices Corp.
Radiology · 193d
Cleared May 25, 2001
GOODNET
K010763 · LLZ
Goodman Co., Ltd.
Radiology · 72d
Cleared May 24, 2001
ULTRAGUIDE MR-GUIDE 3000
K011418 · LNH
Ultraguide , Ltd.
Radiology · 15d
Cleared May 23, 2001
DCM 1.0
K011246 · MUJ
Mds Nordion
Radiology · 30d
Cleared May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared May 22, 2001
VHF ULTRASONIC ARC-SCAN SYSTEM
K003890 · IYO
Ultralink, LLC
Radiology · 155d
Cleared May 21, 2001
CARDIAC VIEW, MODEL 2001
K010513 · MOS
Magna-Lab, Inc.
Radiology · 89d
Cleared May 21, 2001
CDMX
K010915 · MUH
Camsight Co., Inc.
Radiology · 55d
Cleared May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
K011188 · IYN
GE Medical Systems
Radiology · 30d
Cleared May 17, 2001
RADCALC, MODEL V.4.0
K010464 · IYE
Lifeline Software, Inc.
Radiology · 90d
Cleared May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · MOS
Usa Instruments, Inc.
Radiology · 65d
Cleared May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · JAK
E-Z-Em, Inc.
Radiology · 30d
Cleared May 15, 2001
OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
K011314 · ITX
Aloka Co., Ltd.
Radiology · 15d
Cleared May 15, 2001
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
K011315 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared May 08, 2001
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
K010472 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 77d
Cleared May 08, 2001
BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
K010691 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 61d