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
10969–10992 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 24, 1996
STENODOC
K946349 · IYO
Specs USA, Inc.
Radiology · 511d
Cleared May 24, 1996
GREEN TEC-2100
K955236 · IWE
Medtec, Inc.
Radiology · 192d
Cleared May 24, 1996
BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000
K955840 · IYO
Diagnostic Ultrasound Corp.
Radiology · 150d
Cleared May 22, 1996
MODEL 555 010 XY CONVERSION(55010)
K960737 · KPQ
Systems Supply Services, Inc.
Radiology · 89d
Cleared May 20, 1996
MODEL KM-25
K951449 · IYO
Koven Technology, Inc.
Radiology · 418d
Cleared May 20, 1996
ORCA
K960907 · OXO
Lunar Corp.
Radiology · 76d
Cleared May 20, 1996
CLINIX MP
K960920 · OWB
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared May 17, 1996
DIAGNOSTIC ULTRASONIC TRANSDUCER
K941593 · IYO
Toshiba America Medical Systems, In.C
Radiology · 777d
Cleared May 14, 1996
VIFS
K955583 · JAK
Konica Medical Corp.
Radiology · 161d
Cleared May 13, 1996
I-SCAN
K960622 · IYO
Ophthalmic Technologies, Inc.
Radiology · 90d
Cleared May 09, 1996
ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE...
K955092 · LLZ
Cemax-Icon, Inc.
Radiology · 184d
Cleared May 09, 1996
ANALYTICAL REVIEW STATION
K955519 · IZI
Camtronics, Ltd.
Radiology · 157d
Cleared May 07, 1996
DIGITAL IMAGE ACQUISITION SYSTEM
K950330 · IYO
International Imaging Electronics
Radiology · 466d
Cleared May 07, 1996
ULTRA COMPACT VIDEO IMAGER
K953165 · LMC
International Imaging Electronics
Radiology · 305d
Cleared May 07, 1996
ADVANTX LCV+
K960575 · IZI
GE Medical Systems
Radiology · 85d
Cleared May 07, 1996
ECHO-COM FOR MS-WINDOWS VERSION 2.0
K960665 · LLZ
Cone Instruments, Inc.
Radiology · 77d
Cleared May 07, 1996
ECHONET
K960946 · LLZ
Lockheed Martin Communications Systems
Radiology · 60d
Cleared May 03, 1996
TANGENT VI TABLE
K961022 · IXR
Fischer Imaging Corp.
Radiology · 50d
Cleared Apr 30, 1996
GE ADVANTAGE WINDOWS REVIEW WORKSTATION
K960613 · LLZ
GE Medical Systems
Radiology · 77d
Cleared Apr 29, 1996
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · IZH
Elscint, Inc.
Radiology · 94d
Cleared Apr 23, 1996
STEREOTACTIC BODY FRAME
K960338 · IYE
Elekta Instrument AB
Radiology · 90d
Cleared Apr 22, 1996
PID-1 PRECISION INTELLIGENT DOSIMETER
K954564 · IYE
Gammex, Inc.
Radiology · 203d
Cleared Apr 22, 1996
THERAVIEW
K960510 · IYE
Infimed, Inc.
Radiology · 77d
Cleared Apr 19, 1996
PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
K960294 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 88d