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
11929–11952 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Feb 18, 1994
CAPINTEC CRC 35R
K935539 · KPT
Capintec Instruments, Inc.
Radiology · 94d
Cleared Feb 17, 1994
REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.
K931483 · IZL
Portable Power Systems, Inc.
Radiology · 330d
Cleared Feb 10, 1994
DIGORA
K934949 · IXK
Orion Corporation Soredex
Radiology · 115d
Cleared Feb 09, 1994
VARIANT OF OCTOSTOP AND OCTOPAQUE
K930124 · KXH
Octostop, Inc.
Radiology · 393d
Cleared Feb 09, 1994
STORZ COMPUSCAN AB
K930278 · IYO
Storz
Radiology · 384d