FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
9889–9912 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 08, 1999
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K993766 · MUJ
Helax AB
Radiology · 30d
Cleared Dec 07, 1999
PHILIPS EASYVISION WORKSTATION
K990329 · LNH
Philips Medical Systems North...
Radiology · 308d
Cleared Dec 03, 1999
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
K992992 · KPS
Toshiba America Medical Systems, In.C
Radiology · 87d
Cleared Dec 03, 1999
OBC-300 BREAST ARRAY COIL
K993776 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Dec 03, 1999
QWH-300 WRIST ARRAY COIL
K993819 · MOS
Mri Devices Corp.
Radiology · 23d
Cleared Nov 26, 1999
PRIMUS
K993425 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Nov 26, 1999
KAC-300 KNEE ARRAY COIL
K993719 · MOS
Mri Devices Corp.
Radiology · 23d
Cleared Nov 26, 1999
MAMEX
K993740 · IZH
Medical Systems Group
Radiology · 22d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
K993763 · IZI
Medis Medical Imaging Systems BV
Radiology · 18d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
K993765 · IZI
Medis Medical Imaging Systems BV
Radiology · 18d
Cleared Nov 26, 1999
QSC-300 SHOULDER ARRAY COILS
K993780 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Nov 24, 1999
CT PERFUSION OPTION
K993791 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 24, 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 23, 1999
AX WORKSTATION DR-VIEWER SOFTWARE OPTION
K992925 · LLZ
Siemens Corp.
Radiology · 85d
Cleared Nov 22, 1999
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · KGI
Norland Medical Systems, Inc.
Radiology · 152d
Cleared Nov 18, 1999
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
K990475 · MUJ
Kps & Assoc., Inc.
Radiology · 275d
Cleared Nov 12, 1999
LEGEND CRF FLUORO AND RAD SYSTEM
K993665 · KPR
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Nov 10, 1999
TERATECH, MODEL 2000 IMAGING IMAGING
K992505 · IYO
Teratech Corp.
Radiology · 106d
Cleared Nov 10, 1999
E.CAM COMPUTER
K992731 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1999
SITE-RITE 3 ULTRASOUND SYSTEM
K993624 · IYO
Dymax Corp
Radiology · 15d
Cleared Nov 09, 1999
EBT ULTRAFAST CT SCANNER SYSTEM
K992740 · JAK
Imatron, Inc.
Radiology · 85d
Cleared Nov 09, 1999
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
K992746 · LNH
Ge Medical Systems, Inc.
Radiology · 85d
Cleared Nov 09, 1999
STINGRAY DR, MODEL 1
K992794 · MQB
Infimed, Inc.
Radiology · 82d
Cleared Nov 09, 1999
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
K992886 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 75d