FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
9577–9600 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 17, 2001
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K003575 · LNI
GE Medical Systems
Radiology · 58d
Cleared Jan 12, 2001
PORTABLE BREAST COMPRESSION DEVICE
K003775 · IYX
Pem Technologies
Radiology · 37d
Cleared Jan 05, 2001
260 CORVUS
K003292 · IYO
Pie Medical
Radiology · 77d
Cleared Jan 04, 2001
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)
K003330 · IYE
Aktina Medical Physics Corp.
Radiology · 72d
Cleared Dec 28, 2000
BRAIN COIL, MODEL 9800GE-64
K003097 · MOS
Midwest Rf, LLC
Radiology · 86d
Cleared Dec 28, 2000
SPECIAL PROCEDURES HEAD COIL
K003386 · MOS
Midwest Rf, LLC
Radiology · 58d
Cleared Dec 27, 2000
PHORMAX EAGLE SCANNER SYSTEM
K001499 · MQB
Phormax Corp.
Radiology · 226d
Cleared Dec 27, 2000
V SCORE WITH AUTO GATE MODEL TBD
K003230 · JAK
Vital Images, Inc.
Radiology · 72d
Cleared Dec 27, 2000
GYROSCAN INTERA 3.0T
K003516 · LNH
Philips Medical Systems North...
Radiology · 43d
Cleared Dec 27, 2000
XISCAN 6000 IMAGING SYSTEM
K003568 · OXO
Xitec, Inc.
Radiology · 37d
Cleared Dec 27, 2000
ALOKA SSD-4000
K003739 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Dec 22, 2000
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
K003270 · JAQ
Nucletron Corp.
Radiology · 65d
Cleared Dec 22, 2000
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
K003366 · MOS
Igc-Medical Advances, Inc.
Radiology · 53d
Cleared Dec 22, 2000
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
K003685 · MOS
Medical Advances, Inc.
Radiology · 22d
Cleared Dec 22, 2000
GE ADVANCE NXI PET SYSTEM
K003849 · KPS
Ge Medical Systems, Inc.
Radiology · 10d
Cleared Dec 21, 2000
MEDIADENT HDX/MMD HDX SP XRAY SENSOR
K002425 · MUH
Multi Media Dental Systems, Inc.
Radiology · 135d
Cleared Dec 21, 2000
MAGNETIC CONCERTO
K003192 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Dec 21, 2000
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
K003264 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 64d
Cleared Dec 21, 2000
INTERACTIVE REAL TIME SCANNING PACKAGE
K003623 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 19, 2000
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
K000081 · JAQ
Isotopes and Metals , Ltd.
Radiology · 343d
Cleared Dec 19, 2000
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
K002942 · LLZ
Philips Medical Systems North...
Radiology · 89d
Cleared Dec 19, 2000
NEURO II
K002964 · LNH
Innovative Magnetic Resonance Imaging...
Radiology · 88d
Cleared Dec 15, 2000
X-POSURE SYSTEM VERSION 2 MAMMO
K003656 · KGI
Pronosco A/S
Radiology · 18d
Cleared Dec 13, 2000
MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL
K003144 · MOS
Medical Advances, Inc.
Radiology · 64d