FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
9553–9576 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Dec 13, 2000
ECAT PET SCANNER
K003241 · KPS
Cti Pet Systems, Inc.
Radiology · 57d
Cleared Dec 11, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K001550 · LLZ
Imatron, Inc.
Radiology · 207d
Cleared Dec 05, 2000
HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
K002782 · LLZ
Nuclear Diagnostics AB
Radiology · 90d
Cleared Dec 05, 2000
MEDIPRIME
K002894 · LLZ
Algotec Systems, Ltd.
Radiology · 78d
Cleared Dec 05, 2000
UBM PLUS, MODEL P45
K003141 · IYO
Paradigm Medical Industries, Inc.
Radiology · 56d
Cleared Dec 01, 2000
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
K002807 · IYO
Acuson Corp.
Radiology · 84d
Cleared Dec 01, 2000
SIREMOBIL ISO-C 3D
K003266 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 44d