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
13489–13512 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 16, 1989
SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
K885127 · LMC
Fischer Imaging Corp.
Radiology · 66d
Cleared Feb 16, 1989
KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
K890097 · LMC
Eastman Kodak Company
Radiology · 37d
Cleared Feb 16, 1989
KODAK PORTABLE IDENTIFICATION CAMERA
K890467 · JAC
Eastman Kodak Company
Radiology · 16d
Cleared Feb 09, 1989
POLARIX 2 AND POLARIX 2E
K884578 · JAA
Dyna-Med
Radiology · 100d
Cleared Feb 09, 1989
3D/DENTAL
K885322 · JAK
Columbia Scientific, Inc.
Radiology · 43d
Cleared Feb 08, 1989
DACA-100
K882933 · LLZ
Visual Cybernetics
Radiology · 210d
Cleared Feb 06, 1989
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
K890191 · IWJ
Amersham Corp.
Radiology · 19d
Cleared Feb 03, 1989
KODAFLEX II RADIATION THERAPY L CASSETTE
K885178 · IXA
Eastman Kodak Company
Radiology · 51d
Cleared Feb 02, 1989
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
K884816 · LNH
Diasonics, Inc.
Radiology · 77d
Cleared Jan 30, 1989
KODAK DENTAL BARRIER PAC
K884827 · IWZ
Eastman Kodak Company
Radiology · 73d
Cleared Jan 25, 1989
DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A
K883359 · IYO
Toshiba Medical Systems
Radiology · 168d
Cleared Jan 24, 1989
MAGNETOM 42 SP AND MAGNETOM 63 SP
K883898 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 131d
Cleared Jan 24, 1989
AMX-110, AMX-II AND AMX-III
K884340 · ILZ
Dyna-Med
Radiology · 102d
Cleared Jan 24, 1989
ACCULITE-PPL 5
K884787 · INE
Medical Alignment Systems
Radiology · 70d
Cleared Jan 19, 1989
VORTECH'S MEDICAL IMAGING GATEWAY
K884434 · LMD
Vortech Data, Inc.
Radiology · 91d
Cleared Jan 18, 1989
EXEL 1800 AND 1800E CT SCANNER
K884670 · JAK
Elscint, Inc.
Radiology · 71d
Cleared Jan 18, 1989
EXEL 2400 AND 2400 ELITE CT SCANNERS
K884671 · JAK
Elscint, Inc.
Radiology · 71d
Cleared Jan 17, 1989
CURIETRON 192 LOW DOSE RATE
K881323 · JAQ
Compagnie Oris Industrie, S.A.
Radiology · 295d
Cleared Jan 17, 1989
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
K884484 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jan 17, 1989
ESP 3-PHASE X-RAY GENERATORS
K884678 · IZO
Elscint, Inc.
Radiology · 70d
Cleared Jan 13, 1989
ACUSON I5100 ULTRASOUND TRANSDUCER
K884632 · IYO
Acuson Corp.
Radiology · 67d
Cleared Jan 12, 1989
HEAD HOLDING DEVICE/SLEEP APNEA
K884493 · IWY
X-Ray Systems
Radiology · 78d
Cleared Jan 11, 1989
BETA 90/50 MOBILE IMAGING TABLE
K884531 · IXR
Beta Medical Products Co.
Radiology · 75d
Cleared Jan 10, 1989
APA-C CATALOG NUMBER A-8001-C
K884299 · IYO
Ausonics Pty , Ltd.
Radiology · 89d