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
12529–12552 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 19, 1991
CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111
K912516 · IZZ
Continental X-Ray Corp.
Radiology · 166d
Cleared Nov 19, 1991
INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
K912600 · ITX
Intertherapy, Inc.
Radiology · 162d
Cleared Nov 19, 1991
STATVIEW
K913755 · LLZ
Image Systems, Inc.
Radiology · 90d
Cleared Nov 19, 1991
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · DPW
Hewlett-Packard Co.
Radiology · 85d
Cleared Nov 19, 1991
FLUROSPOT H VERSION 2
K914525 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Nov 07, 1991
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
K912404 · DPT
Hewlett-Packard Co.
Radiology · 161d
Cleared Nov 07, 1991
VARIAN C-SERIES CLINACS (CLINAC 2300C/D)
K913119 · IYE
Varian Assoc., Inc.
Radiology · 115d
Cleared Nov 07, 1991
UNICATH EP.
K913685 · IZI
Xre Corp.
Radiology · 80d
Cleared Nov 05, 1991
ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
K912250 · IWB
Theta Systems, Inc.
Radiology · 168d
Cleared Nov 05, 1991
ORTHOPANTOMOGRAPH 100
K912893 · EHD
Instrumentarium Corp.
Radiology · 127d
Cleared Nov 05, 1991
VARIAN CLINAC 600SR
K913174 · IYE
Varian Assoc., Inc.
Radiology · 125d
Cleared Nov 05, 1991
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
K913577 · IZO
Control-X, Inc.
Radiology · 85d
Cleared Nov 05, 1991
X-RAY TABLE
K914165 · IXR
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Nov 04, 1991
XKNIFE RADIOSURGERY SYSTEM
K912630 · IYE
Rsa, Inc.
Radiology · 140d
Cleared Nov 01, 1991
HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE
K913264 · LLZ
Mallinckrodt Group, Inc.
Radiology · 101d
Cleared Nov 01, 1991
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · KGI
Hologic, Inc.
Radiology · 99d
Cleared Nov 01, 1991
40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE
K913325 · LNH
Resonex, Inc.
Radiology · 99d
Cleared Nov 01, 1991
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
K913578 · IZO
Control-X, Inc.
Radiology · 81d
Cleared Nov 01, 1991
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
K914019 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 53d
Cleared Nov 01, 1991
ER-1000 CATHERIZATION C-ARM SYSTEMS
K914348 · IYB
Shimadzu Medical Systems
Radiology · 35d
Cleared Oct 31, 1991
ACUSON V510 TRANSDUCER
K911767 · ITX
Acuson Corp.
Radiology · 195d
Cleared Oct 30, 1991
SMT-100X
K911975 · LNH
Shimadzu Medical Systems
Radiology · 180d
Cleared Oct 30, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K913475 · LNH
GE Medical Systems
Radiology · 86d
Cleared Oct 30, 1991
COFFMAN TOMOGRAPH
K913652 · EHD
Coffman Dental
Radiology · 75d