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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,520 results
11041–11064 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 11, 1996
SIREGRAPH CF
K960266 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Mar 07, 1996
ULTRA EASE
K950943 · IYO
Lectec Corp.
Radiology · 385d
Cleared Mar 07, 1996
TREATMENT MANAGEMENT SYSTEM
K953391 · LHN
Siemens Medical Solutions USA, Inc.
Radiology · 232d
Cleared Mar 07, 1996
FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM
K960326 · LMB
Fujifilm Medical System U.S.A., Inc.
Radiology · 43d
Cleared Mar 05, 1996
VERSION 3.7 OPERATING SYSTEM SOFTWARE
K960181 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Mar 01, 1996
DIAGNOSTIC ULTRASOUND TRANSDUCER
K953759 · ITX
Biosound, Inc.
Radiology · 203d
Cleared Mar 01, 1996
DIAGNOSTIC ULTRASOUND TRANDUCER
K953819 · ITX
Biosound, Inc.
Radiology · 199d
Cleared Mar 01, 1996
ALARA IMAGING SYSTEM
K955643 · EGY
Denoptix, Inc.
Radiology · 80d
Cleared Mar 01, 1996
COMPUMED DICON CLIENT
K955708 · LMD
Compumed, Inc.
Radiology · 78d
Cleared Mar 01, 1996
ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM
K960028 · EAP
Dentsply Intl.
Radiology · 59d
Cleared Feb 27, 1996
PREVIEW SURGERY PLANNING SOFTWARE
K953616 · LLZ
Medical Media Systems
Radiology · 208d
Cleared Feb 27, 1996
IDXVIEW
K954071 · LMD
Idx Systems Corp.
Radiology · 181d
Cleared Feb 27, 1996
MEDRAD/HITACHI BREAST IMAGING SURFACE COIL
K955626 · MOS
Medrad, Inc.
Radiology · 78d
Cleared Feb 27, 1996
G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
K960146 · IZG
GE Medical Systems
Radiology · 42d
Cleared Feb 26, 1996
AURORA IMAGING SYSTEM
K950837 · LNH
Advanced Mammography Systems, Inc.
Radiology · 367d
Cleared Feb 26, 1996
COMPUTE-RX PLAN PC3D
K953508 · IYE
Medicalibration Physics Consultant...
Radiology · 215d
Cleared Feb 26, 1996
SPECTEF PROTOCOL
K954874 · KPS
GE Medical Systems
Radiology · 125d
Cleared Feb 21, 1996
VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)
K952238 · LMB
Imaging Concepts, Inc.
Radiology · 285d
Cleared Feb 21, 1996
DICOMVIEW
K954479 · LMD
Heartlab, Inc.
Radiology · 148d
Cleared Feb 21, 1996
ECOGEL 200 ULTRASOUND GEL
K955246 · ITX
Eco-Med Pharmaceuticals, Inc.
Radiology · 98d
Cleared Feb 21, 1996
SIENET TELERADIOLOGY PRODUCT LINE
K955394 · LMC
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Feb 13, 1996
SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K953634 · IYO
Shimadzu Medical Systems
Radiology · 195d
Cleared Feb 12, 1996
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
K952892 · ITX
Olympus America, Inc.
Radiology · 234d
Cleared Feb 12, 1996
ULTRASOUND PROBE BIOPSY ACCESSORIES
K955458 · ITX
Biosound, Inc.
Radiology · 75d