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
9601–9624 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Nov 17, 2000
MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
K002840 · IZI
The Phantom Laboratory, Inc.
Radiology · 66d
Cleared Nov 17, 2000
CT CORD IQ OPTION 1.0
K003408 · JAK
GE Medical Systems
Radiology · 15d
Cleared Nov 16, 2000
ECAT ACCEL PET SCANNER
K002584 · KPS
Cti Pet Systems, Inc.
Radiology · 87d
Cleared Nov 16, 2000
INVAC
K002608 · IYE
Duncan Hynd Associates, Ltd.
Radiology · 87d
Cleared Nov 16, 2000
HRH-63 HEAD ARRAY COIL
K002774 · MOS
Mri Devices Corp.
Radiology · 71d