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
9409–9432 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Nov 30, 2000
OS-2000 OPTICAL SONOGRAPHY SYSTEM
K001510 · NCS
Advanced Diagnostics, Inc.
Radiology · 199d
Cleared Nov 29, 2000
DELTA 32 AND DELTA 32 TACT
K002472 · IZH
Instrumentarium Imaging, Inc.
Radiology · 110d
Cleared Nov 28, 2000
SURGI-VISION PROSTATE COIL
K002916 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Nov 28, 2000
DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
K003473 · IZH
Elscintec Systems , Ltd.
Radiology · 20d
Cleared Nov 22, 2000
T.I.M.S., VERSION 2.00
K001947 · LLZ
Total Medical Information Management...
Radiology · 149d
Cleared Nov 22, 2000
MODEL 6900GE-64: C-SPINE ARRAY
K002860 · MOS
Midwest Rf, LLC
Radiology · 70d
Cleared Nov 22, 2000
VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM
K003525 · IYN
Medison America, Inc.
Radiology · 7d
Cleared Nov 21, 2000
MODEL 6600GE-64: TRAMA NECK ARRAY
K002864 · MOS
Midwest Rf, LLC
Radiology · 69d
Cleared Nov 17, 2000
VAGINAL APPLICATOR SHIELDED
K001544 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 183d
Cleared Nov 17, 2000
CN ACQUISITION STATION
K002597 · LLZ
Cardionow, Inc.
Radiology · 88d
Cleared Nov 17, 2000
NUMALINK
K002724 · LLZ
Numa, Inc.
Radiology · 78d
Cleared Nov 17, 2000
VIATRONIX VISUALIZATION SYSTEM (VVS)
K002780 · LLZ
Viatronix, Inc.
Radiology · 72d