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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
13417–13440 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 17, 1989
GE MR MAX SYSTEM
K895794 · LNH
GE Medical Systems
Radiology · 50d
Cleared Nov 17, 1989
FEMORAL ANGIOGRAPHY DRAPE
K896088 · IZI
Medical Plastics, Inc.
Radiology · 29d
Cleared Nov 15, 1989
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
K894056 · KPS
Shimadzu Medical Systems
Radiology · 161d
Cleared Nov 15, 1989
1989 SOFTWARE REVISION TO THE BMT-1100
K894714 · LNH
Bruker Medical Imaging, Inc.
Radiology · 114d
Cleared Nov 15, 1989
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C
K895034 · IXY
Yamato Medical Corp.
Radiology · 99d
Cleared Nov 15, 1989
DIGICAM LHP (VIDEO INTERFACE OPTION)
K895668 · LMC
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Nov 13, 1989
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
K895394 · JAA
Shimadzu Corp.
Radiology · 68d
Cleared Nov 13, 1989
MODIFIED SPANTRON FRAME FREEZE
K895546 · JAA
Spantron, Inc.
Radiology · 61d
Cleared Nov 13, 1989
RADKOR DXG-650R
K895969 · IZO
Radkor, Inc.
Radiology · 32d
Cleared Nov 06, 1989
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
K893744 · LNH
Shimadzu Medical Systems
Radiology · 172d
Cleared Nov 06, 1989
ULTRANET-S COLLIMATOR
K894142 · IZW
GE Medical Systems
Radiology · 146d
Cleared Nov 06, 1989
PATIENT POSITIONING ACCESSORIES
K895500 · IYE
Perkins Mfg. Co.
Radiology · 55d
Cleared Nov 06, 1989
X-RAY EQUIPMENT (VARIOUS TYPES)
K895730 · JAA
Continental X-Ray Corp.
Radiology · 45d
Cleared Nov 03, 1989
ECHO GEL (RAINFOREST)
K895100 · ITX
Lead-Lok, Inc.
Radiology · 80d
Cleared Nov 02, 1989
MODIFIED POSICAM SYSTEM MODEL 6.5
K894998 · KPS
Positron
Radiology · 86d
Cleared Nov 01, 1989
FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE
K895320 · LLZ
Digivision, Inc.
Radiology · 64d
Cleared Oct 30, 1989
VISTA MR 2055 HP SYSTEM
K895151 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 81d
Cleared Oct 27, 1989
CURIETRON 192 HIGH DOSE RATE
K890799 · JAQ
Cis-Us, Inc.
Radiology · 252d
Cleared Oct 27, 1989
MIPRON/UMIPRON
K891689 · LLZ
Kontron Electronics
Radiology · 219d
Cleared Oct 27, 1989
MIP MR
K891692 · LLZ
Kontron Electronics
Radiology · 219d
Cleared Oct 27, 1989
VIEW 1000
K891695 · LLZ
Virtual Imaging
Radiology · 219d
Cleared Oct 27, 1989
MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS
K892397 · LLZ
Nuccardiac Software, Inc.
Radiology · 203d
Cleared Oct 27, 1989
MT/S SOFTWARE RELEASE 5.0.
K893518 · LNH
Diasonics, Inc.
Radiology · 172d
Cleared Oct 27, 1989
RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS
K894742 · ITY
Inmark Corp.
Radiology · 102d