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
9049–9072 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 06, 2002
DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
K012439 · LLZ
Radco Data AB
Radiology · 190d
Cleared Feb 06, 2002
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
K013723 · ITX
Hitachi Medical Corp.
Radiology · 89d
Cleared Feb 06, 2002
HANDHELD GAMMA FINDER (HGF)
K013751 · IZD
Silicon Instruments Gmhb
Radiology · 85d
Cleared Feb 06, 2002
MARK 5000 QUADRATURE SHOULDER COIL
K013854 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Feb 06, 2002
LOGIQ 3
K020263 · IYN
General Electric Co.
Radiology · 12d
Cleared Feb 05, 2002
CANVAS N-VAS-D 2.0
K014011 · LNH
Vassol, Inc.
Radiology · 62d
Cleared Feb 05, 2002
CTL BODY / SPINE ARRAY COIL
K014086 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Feb 04, 2002
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · FDS
Pentax Precision Instrument Corp.
Radiology · 91d
Cleared Feb 04, 2002
VERAVIEWEPOCS, MODEL VE
K013955 · EHD
J. Morita USA, Inc.
Radiology · 66d
Cleared Feb 01, 2002
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K013826 · KPR
Siemens Medical Systems, Inc.
Radiology · 74d
Cleared Feb 01, 2002
SCANX
K013893 · MUH
Air Techniques, Inc.
Radiology · 70d
Cleared Feb 01, 2002
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
K013985 · MOS
Machnet BV
Radiology · 60d
Cleared Feb 01, 2002
MODIFICATION TO VIEWSEND MEDICAL
K013994 · LLZ
Klt Telecom, Inc.
Radiology · 59d
Cleared Feb 01, 2002
EXS-63 SMALL EXTREMITY ARRAY COIL
K020036 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Feb 01, 2002
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
K020070 · EHD
Progeny, Inc.
Radiology · 23d
Cleared Jan 31, 2002
HUMPHREY OCT3
K012727 · IYO
Carl Zeiss Ophthalmic Systems, Inc.
Radiology · 169d
Cleared Jan 28, 2002
BCC GAMMA CAMERA
K013667 · KPS
Is2 Research, Inc.
Radiology · 83d
Cleared Jan 28, 2002
HI-ART SYSTEM
K013673 · MUJ
Tomo Therapy, Inc.
Radiology · 83d
Cleared Jan 28, 2002
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
K013922 · LLZ
Barco N.V.
Radiology · 62d
Cleared Jan 28, 2002
VOXAR'S CALCIUM SCORING PRODUCT
K020140 · LLZ
Voxar Limited
Radiology · 12d
Cleared Jan 24, 2002
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
K013636 · LNH
GE Medical Systems
Radiology · 80d
Cleared Jan 24, 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · KXK
Cp Medical
Radiology · 52d
Cleared Jan 22, 2002
BODY ARRAY COIL
K013594 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Jan 22, 2002
PREMIER III PHASED ARRAY CTL SPINE COIL
K013595 · MOS
Usa Instruments, Inc.
Radiology · 84d