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
11689–11712 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 16, 1994
NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM
K935570 · LNH
Resonex, Inc.
Radiology · 118d
Cleared Mar 16, 1994
PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER
K935580 · OXO
Precise Optics
Radiology · 118d
Cleared Mar 16, 1994
MAGNETOM OPEN
K935661 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Mar 16, 1994
FAST SPIN ECHO
K935664 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 110d
Cleared Mar 16, 1994
TC+ SYSTEM (TILTING C-ARM SYSTEM)
K936180 · OWB
GE Medical Systems
Radiology · 79d
Cleared Mar 16, 1994
SHIMADZU MOBILE X-RAY SYSTEMS
K940294 · OXO
Shimadzu Precision Instruments, Inc.
Radiology · 54d
Cleared Mar 16, 1994
STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
K940539 · KPY
Standard Imaging, Inc.
Radiology · 37d
Cleared Mar 16, 1994
SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
K940696 · KXJ
Philips Medical Systems North...
Radiology · 28d
Cleared Mar 15, 1994
ORION DIAGNOSTIC ULTRASOUND SYSTEM
K930768 · IYO
GE Medical Systems
Radiology · 392d
Cleared Mar 07, 1994
SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE
K935694 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 98d
Cleared Mar 04, 1994
VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM
K931460 · LNH
General Electric Co.
Radiology · 346d
Cleared Mar 04, 1994
MODEL MPFT-01, GENESIS
K934574 · IXR
International Medical Designs, Inc.
Radiology · 169d
Cleared Feb 25, 1994
SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS
K935318 · KPS
Summit Nuclear
Radiology · 113d
Cleared Feb 24, 1994
AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN
K932403 · LNH
Medrad, Inc.
Radiology · 297d
Cleared Feb 22, 1994
MED-GENESIS PATIENT LASER EYE SHIELD
K934459 · IWS
Med-Genesis, Inc.
Radiology · 165d
Cleared Feb 19, 1994
ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
K934549 · IWR
Victoreen, Inc.
Radiology · 150d
Cleared Feb 18, 1994
AD/V A.5
K925799 · LMA
Adaptive Video, Inc.
Radiology · 459d
Cleared Feb 18, 1994
NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM
K931410 · LMB
Novus Technologies, Inc.
Radiology · 336d
Cleared Feb 18, 1994
SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM
K932244 · LNH
Shimadzu Medical Systems
Radiology · 284d
Cleared Feb 18, 1994
CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARE
K932371 · LLZ
Cemax, Inc.
Radiology · 280d
Cleared Feb 18, 1994
APEX SPX CARDIAL
K932673 · IYX
Elscint, Inc.
Radiology · 261d
Cleared Feb 18, 1994
MRT-50GP
K933018 · LNH
Toshiba America Mri, Inc.
Radiology · 241d
Cleared Feb 18, 1994
CARBON FIBER PALLET
K934766 · IYX
Siemens Gammasonics, Inc.
Radiology · 137d
Cleared Feb 18, 1994
GX-770 X-RAY CONTROL, MODEL 46-404600G4
K935046 · EHD
Gendex Corp.
Radiology · 121d