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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
10873–10896 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 26, 1997
VIPOR UNIT
K964322 · JAA
Tilane Corp.
Radiology · 120d
Cleared Feb 26, 1997
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER...
K964813 · MOS
Medical Advances, Inc.
Radiology · 89d
Cleared Feb 26, 1997
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
K964990 · JAA
Hitachi Medical Systems America, Inc.
Radiology · 72d
Cleared Feb 26, 1997
PM 2002 CC PROLINE
K970263 · EHD
Planmeca Oy
Radiology · 34d
Cleared Feb 24, 1997
KINEMATIC POSITIONING DEVICES
K964752 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 89d
Cleared Feb 24, 1997
HI-STAR MRI IMAGING SYSTEM
K964778 · LNH
Health Images, Inc.
Radiology · 89d
Cleared Feb 21, 1997
RHEO DOPPLEX II (RD 2)
K964699 · IYN
Huntleigh Technology, Inc.
Radiology · 88d
Cleared Feb 21, 1997
PRISM XPVT SYSTEM (210823)
K964712 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 19, 1997
COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
K940942 · IYO
Medison America, Inc.
Radiology · 1086d
Cleared Feb 19, 1997
ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
K961073 · IYO
Atlantis Diagnostics Intl., Inc.
Radiology · 338d
Cleared Feb 18, 1997
MODELS EXL AND EXS EXTREMITY COIL SET
K964668 · MOS
Mri Devices Corp.
Radiology · 89d
Cleared Feb 14, 1997
OASIS
K964658 · ITX
Sonotech, Inc.
Radiology · 86d
Cleared Feb 11, 1997
ULTRASOUND SYSTEM MODEL UF-3500
K955543 · IYO
Fukuda Denshi USA, Inc.
Radiology · 434d
Cleared Feb 11, 1997
PHASED ARRAY NECK COIL
K964678 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 82d
Cleared Feb 11, 1997
THE NOMOS MINICRANE
K964740 · JAI
Nomos Corp.
Radiology · 77d
Cleared Feb 11, 1997
MATRIX 3000 FLEXIBLE SPINE COIL
K964753 · LNH
Us Asia Instruments, Inc.
Radiology · 76d
Cleared Feb 11, 1997
UNIVISION ECHOCARDIOLOGY SYSTEM
K964803 · LMB
Network Concepts, Inc.
Radiology · 74d
Cleared Feb 11, 1997
BEAM BLOCK TRAYS
K964840 · IYE
Aktina Medical Physics Corp.
Radiology · 74d
Cleared Feb 11, 1997
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K964854 · MOS
Medrad, Inc.
Radiology · 70d
Cleared Feb 10, 1997
GAMMA GUIDANCE SYSTEM
K961321 · IZD
Radiation Monitoring Devices, Inc.
Radiology · 311d
Cleared Feb 10, 1997
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
K961974 · ITX
Pentax Precision Instrument Corp.
Radiology · 266d
Cleared Feb 10, 1997
PROTEC (1024)
K963730 · KPS
Proportional Technologies, Inc.
Radiology · 147d
Cleared Feb 10, 1997
SHEATHES (NON-LATEX)
K963831 · ITX
Medical Resources
Radiology · 139d
Cleared Feb 10, 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
K964626 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 83d