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
12745–12768 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 27, 1991
MRT-150A
K914012 · LNH
Toshiba America Mri, Inc.
Radiology · 79d
Cleared Nov 27, 1991
P2020-8-0 BEAM-LIMITING DEVICE
K914184 · KPW
Precise Optics
Radiology · 70d
Cleared Nov 27, 1991
MICRO-X 50 HF
K914236 · IZO
Fischer Imaging Corp.
Radiology · 68d
Cleared Nov 27, 1991
MICRO-X 30 HF
K914266 · IZO
Fischer Imaging Corp.
Radiology · 65d
Cleared Nov 27, 1991
CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC
K914296 · KPS
Nuccardiac Software, Inc.
Radiology · 63d
Cleared Nov 27, 1991
HICOR
K914313 · IZI
Siemens Gammasonics, Inc.
Radiology · 65d
Cleared Nov 27, 1991
MODEL 311GE-64: WHOLE VOLUME NECK COIL
K914535 · LNH
Medical Advances, Inc.
Radiology · 47d
Cleared Nov 27, 1991
MODELS 190GE-64/191GE-64/192GE-64/193GE-64
K914536 · LNH
Medical Advances, Inc.
Radiology · 47d
Cleared Nov 25, 1991
RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM
K913869 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 22, 1991
PHILIPS RIGID VOLUME COILS
K911872 · LNH
Philips Medical Systems, Inc.
Radiology · 210d
Cleared Nov 22, 1991
MRH-500
K911993 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 199d
Cleared Nov 22, 1991
RECORD AND VERIFY MEVATRON ADAPTER
K913674 · IYE
Computerized Medical Systems, Inc.
Radiology · 95d
Cleared Nov 22, 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K913996 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Nov 22, 1991
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
K914263 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 60d
Cleared Nov 22, 1991
I-125 SEEDS IN CARRIER, CODE: 6720
K914268 · KXK
Medi-Physics Inc. Dba Nycomed...
Radiology · 60d
Cleared Nov 22, 1991
I-125 SEEDS, CODE: 6711
K914281 · KXK
Medi-Physics Inc. Dba Nycomed...
Radiology · 59d
Cleared Nov 22, 1991
ICON COMPUTER SYSTEM
K914350 · JWM
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Nov 22, 1991
CEQUAL(TM)
K914527 · KPS
General Electric Co.
Radiology · 43d
Cleared Nov 19, 1991
INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM
K911114 · ITX
Interson Corp.
Radiology · 257d
Cleared Nov 19, 1991
CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111
K912516 · IZZ
Continental X-Ray Corp.
Radiology · 166d
Cleared Nov 19, 1991
INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
K912600 · ITX
Intertherapy, Inc.
Radiology · 162d
Cleared Nov 19, 1991
STATVIEW
K913755 · LLZ
Image Systems, Inc.
Radiology · 90d
Cleared Nov 19, 1991
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · DPW
Hewlett-Packard Co.
Radiology · 85d
Cleared Nov 19, 1991
FLUROSPOT H VERSION 2
K914525 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 40d