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
9385–9408 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 31, 2001
EFILM WORKSTATION
K012211 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Jul 26, 2001
RF-IVD WIRELESS DOSIMETER-MODEL 1133
K011332 · IYE
Sun Nuclear Corp.
Radiology · 85d
Cleared Jul 26, 2001
TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC...
K012191 · IYN
Teratech Corp.
Radiology · 13d
Cleared Jul 20, 2001
NORTHEAST PROTON THERAPY CENTER
K983332 · LHN
Massachusetts General Hospital
Radiology · 1032d
Cleared Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
K011296 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 80d
Cleared Jul 17, 2001
AMERITEK BRACHYTHERAPY TEMPLATE
K011581 · ITX
Amertek Medical, Inc.
Radiology · 55d
Cleared Jul 12, 2001
IMMOBILIZATION SYSTEM FOR ENT
K003779 · IYE
Arplay Medical S.A.
Radiology · 217d
Cleared Jul 12, 2001
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
K011155 · KXK
Ibt, Inc.
Radiology · 87d
Cleared Jul 12, 2001
VARISEED 7.0
K012017 · MUJ
Varian Medical Systems
Radiology · 14d
Cleared Jul 12, 2001
VOXAR VC, MODEL 1.0
K012072 · LLZ
Voxar Limited
Radiology · 10d
Cleared Jul 12, 2001
VORTEX
K012097 · LLZ
Ultravisual Medical Systems
Radiology · 7d
Cleared Jul 12, 2001
PROTON THERAPY SYSTEM
K983024 · LHN
Ion Beam Applications S.A.
Radiology · 1046d
Cleared Jul 11, 2001
TELEPAX
K011173 · LLZ
Imed Systems & Consulting, LLC
Radiology · 85d
Cleared Jul 11, 2001
MODIFIED M-IV MAMMOGRAPHY SYSTEM
K011987 · IZH
Lorad, A Hologic Co.
Radiology · 15d
Cleared Jul 10, 2001
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
K011205 · KXK
Isoaid
Radiology · 82d
Cleared Jul 10, 2001
UROLOGIC
K011311 · OWB
Pck Electronic Industry and Trade Co,...
Radiology · 71d
Cleared Jul 03, 2001
SMART RAD
K003438 · MQB
Cmt Medical Technologies, Ltd.
Radiology · 239d
Cleared Jul 03, 2001
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
K011141 · JAK
Shimadzu Corp.
Radiology · 81d
Cleared Jun 29, 2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · EHD
Planmeca Oy
Radiology · 35d
Cleared Jun 27, 2001
CYPRESS SYSTEM
K010950 · IYO
Acuson Corp.
Radiology · 90d
Cleared Jun 27, 2001
CT/MASTER, VERSION 1.0
K011180 · JAK
Columbia Scientific, Inc.
Radiology · 71d
Cleared Jun 26, 2001
SYNGO MULTIMODALITY WORKSTATION
K010938 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Jun 25, 2001
BRACHYSEED PD-103 MODELS #PD1
K011119 · KXK
Draximage, Inc.
Radiology · 74d
Cleared Jun 20, 2001
PTW DOSIMETRY DIODE, T60008
K010916 · IYE
Ptw-New York Corp.
Radiology · 85d