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
9601–9624 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 08, 2000
QWH-149 WRIST ARRAY COIL
K003331 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Nov 08, 2000
OBC-149 BREAST ARRAY COIL
K003340 · MOS
Mri Devices Corp.
Radiology · 14d
Cleared Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · MUJ
Brainlab AG
Radiology · 80d
Cleared Oct 31, 2000
CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
K002590 · LLZ
Cedara Software Corp.
Radiology · 71d
Cleared Oct 31, 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
K002611 · LNH
GE Medical Systems
Radiology · 70d
Cleared Oct 31, 2000
ECAT PET SCANNER
K002715 · KPS
Cti Pet Systems, Inc.
Radiology · 61d
Cleared Oct 27, 2000
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 80d
Cleared Oct 26, 2000
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
K002531 · LNH
Toshiba America Mri, Inc.
Radiology · 71d
Cleared Oct 26, 2000
300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
K002880 · IYN
Pie Medical
Radiology · 41d
Cleared Oct 25, 2000
PIPER
K001295 · MUJ
Rtek Medical Systems, LLC
Radiology · 184d
Cleared Oct 25, 2000
POWER 5000 GENERAL PURPOSE COIL
K002483 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Oct 25, 2000
OPART, MODEL MRT-600
K002522 · MOS
Toshiba America Mri, Inc.
Radiology · 71d
Cleared Oct 24, 2000
RADIOMED SOURCE
K001070 · KXK
Radiomed Corp.
Radiology · 204d
Cleared Oct 24, 2000
SOMATOM SMILE
K003152 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 23, 2000
DMLC IV-ERGO
K001163 · IXI
3D Line USA, Inc.
Radiology · 196d
Cleared Oct 23, 2000
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K002446 · KXK
Sun Nuclear Corp.
Radiology · 75d
Cleared Oct 23, 2000
X-POSURE SYSTEM VERSION 2 RAD
K002500 · KGI
Pronosco A/S
Radiology · 70d
Cleared Oct 20, 2000
RADIOCAMERAS EXTRACRANIAL SYSTEM
K000246 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 267d
Cleared Oct 20, 2000
WACKERS-LIU CQ SOFTWARE
K002229 · KPS
Eclipse Systems, Inc.
Radiology · 88d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 19, 2000
VITREA 2, VERSION 2.1
K002519 · LLZ
Vital Images, Inc.
Radiology · 65d
Cleared Oct 18, 2000
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
K002444 · IYE
Sun Nuclear Corp.
Radiology · 70d
Cleared Oct 17, 2000
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS
K002198 · OWB
Fluoro Scan Imaging Systems, Inc.
Radiology · 89d