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
12001–12024 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 26, 1993
MODEL 600GE-64: BILATERAL BREAST COIL
K930122 · LNH
Medical Advances, Inc.
Radiology · 195d
Cleared Jul 26, 1993
MAMMORX
K930246 · IYE
Diacor, Inc.
Radiology · 188d
Cleared Jul 26, 1993
RINN UNIVERSAL COLLIMATOR
K932134 · IZX
Rinn Corp.
Radiology · 84d
Cleared Jul 26, 1993
FUJI EC ID CAMERA
K932357 · JAC
Fujifilm Medical System U.S.A., Inc.
Radiology · 73d
Cleared Jul 26, 1993
FUJIFILM EC-B SERIES CASETTE
K932565 · IXA
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Jul 26, 1993
GXP DENTAL X-RAY PROCESSOR
K932675 · EGN
Gendex Corp.
Radiology · 54d
Cleared Jul 23, 1993
DTX-100
K926300 · KGI
Hologic, Inc.
Radiology · 221d
Cleared Jul 23, 1993
9170, 1170
K932354 · IZL
Dynarad Corp.
Radiology · 71d
Cleared Jul 22, 1993
STERILE LEMAITRE GLOW 'N TELL TAPE
K932184 · KFX
Vascutech, Inc.
Radiology · 78d
Cleared Jul 21, 1993
CVIS INSIGHT IMAGING GUIDE CATHETER
K930232 · DQO
Cardiovascular Imaging Systems, Inc.
Radiology · 183d
Cleared Jul 21, 1993
3M MEDICAL DIAGNOSTIC VIDEOCASSETTE
K931604 · IWZ
3M Health Care, Ltd.
Radiology · 111d
Cleared Jul 20, 1993
MATRIX CCM 600
K926009 · IYO
Heraeus Kulzer, Inc.
Radiology · 230d
Cleared Jul 20, 1993
MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15
K926571 · LNH
Medrad, Inc.
Radiology · 201d
Cleared Jul 20, 1993
FATHOM CMP-1000
K930051 · IYO
Fathom Ent., Inc.
Radiology · 195d
Cleared Jul 20, 1993
3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE
K931605 · IWZ
3M Health Care, Ltd.
Radiology · 110d
Cleared Jul 20, 1993
SUNSCOPE 100
K931941 · JAA
Sunning Corp.
Radiology · 92d
Cleared Jul 19, 1993
URETERAL COMPRESSION DEVICE
K931268 · JAA
Bt Medical Co., Inc.
Radiology · 133d
Cleared Jul 14, 1993
ALPHA II
K931725 · EHD
Dynarad Corp.
Radiology · 100d
Cleared Jul 13, 1993
ALPHA
K930273 · IZZ
Raymax Medical Corp.
Radiology · 175d
Cleared Jul 13, 1993
ACCESSORY TO UNIVERSAL OCTOPAQUE
K930357 · KXH
Octostop, Inc.
Radiology · 168d
Cleared Jul 13, 1993
PNEUMATIC COMPRESSION DEVICE
K930885 · JAA
Bt Medical Co., Inc.
Radiology · 145d
Cleared Jul 13, 1993
INTREX INTERORAL DENTAL X-RAY UNIT
K930925 · EAP
Keystone X-Ray, Inc.
Radiology · 140d
Cleared Jul 13, 1993
BATTERY PACKS (VARIOUS MODELS)
K931200 · IZL
Access / God Loves You
Radiology · 126d
Cleared Jul 08, 1993
COMBISON(R) 311
K925354 · IYO
Kretztechnik AG
Radiology · 259d