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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
9913–9936 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 21, 1999
PENSIL TRAUMA, MODEL WWS6100
K993962 · KPR
Wuestec Medical, Inc.
Radiology · 57d
Cleared Dec 20, 1999
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM
K994096 · IYN
Sonosite,Inc.
Radiology · 17d
Cleared Dec 15, 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · DQO
Acuson Corp.
Radiology · 131d
Cleared Dec 15, 1999
SYSTEM 2100
K993530 · LLZ
Math Solutions, LLC
Radiology · 58d
Cleared Dec 15, 1999
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST...
K993532 · LLZ
Impax Technology, Inc.
Radiology · 57d
Cleared Dec 15, 1999
CONFORMAX MMLC VR1
K993594 · IYE
Radionics, Inc.
Radiology · 51d
Cleared Dec 15, 1999
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K993597 · LMA
Vidar Systems Corp.
Radiology · 51d
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