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
8761–8784 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 09, 2003
PACSPLUS
K023460 · LLZ
Medical Standard Co., Ltd.
Radiology · 86d
Cleared Jan 09, 2003
PERFORMA STEREO
K023864 · IZH
Instrumentarium Corp. Imaging Division
Radiology · 50d
Cleared Jan 09, 2003
QWH-250-PAN WRIST ARRAY COIL
K024209 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Jan 09, 2003
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
K024352 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Jan 09, 2003
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
K024354 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Jan 07, 2003
ACCULEAF
K021338 · IYE
Direx Systems Corp.
Radiology · 256d
Cleared Jan 07, 2003
UNISIGHT SYSTEM WITH UNIGATE
K023394 · LLZ
Electronic Business Machine Co., Ltd....
Radiology · 90d
Cleared Jan 07, 2003
HCP DICOM NET
K023467 · LLZ
Softlink International, Inc.
Radiology · 83d
Cleared Jan 07, 2003
UNIPACS WORKSTATION
K023476 · LLZ
Universal Pacs, Inc.
Radiology · 83d
Cleared Jan 07, 2003
OBC-250-PAN BREAST ARRAY COIL
K024208 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Jan 03, 2003
TROPHYPAN
K023346 · MUH
Trophy Radiologie
Radiology · 88d
Cleared Jan 03, 2003
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
K023373 · IYX
Gvi Technology Partners
Radiology · 87d
Cleared Jan 03, 2003
LIFEDOP DOPPLER
K024197 · KNG
Summit Doppler Systems, Inc.
Radiology · 14d
Cleared Dec 27, 2002
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
K021987 · IXI
S&S Par Scientific
Radiology · 192d
Cleared Dec 24, 2002
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
K022517 · IYN
U-Systems, Inc.
Radiology · 147d
Cleared Dec 23, 2002
AMALGA PACS
K023246 · LLZ
Global Care Solutions, S.A.
Radiology · 84d
Cleared Dec 23, 2002
CHAMPION 5000 PERIPHERAL VASCULAR COIL
K023247 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Dec 23, 2002
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
K023293 · IYE
Med-Tec,Inc.
Radiology · 82d
Cleared Dec 23, 2002
CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023322 · LLZ
Barco N.V.
Radiology · 80d
Cleared Dec 23, 2002
IMAGETILE
K023339 · LLZ
Barco N.V.
Radiology · 77d
Cleared Dec 23, 2002
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023340 · LLZ
Barco N.V.
Radiology · 77d
Cleared Dec 23, 2002
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023341 · LLZ
Barco N.V.
Radiology · 77d
Cleared Dec 23, 2002
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
K023877 · LLZ
Philips Ultrasound, Inc.
Radiology · 32d
Cleared Dec 20, 2002
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
K023154 · DXC
Vascular Control Systems, Inc.
Radiology · 88d