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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
9721–9744 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 19, 2000
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001754 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 17, 2000
MEDICAL IMAGE MERGE (MIM)
K001276 · KPS
Syntermed, Inc.
Radiology · 87d
Cleared Jul 17, 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K001582 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Jul 17, 2000
PHARMASEED, MODEL BT-125-3
K994018 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 234d
Cleared Jul 14, 2000
PHARMASEED, MODEL BT-103-3
K994016 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 231d
Cleared Jul 13, 2000
FOCUS
K001729 · EHD
Instrumentarium Corp.
Radiology · 36d
Cleared Jul 13, 2000
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001747 · LLZ
Barco NV Display Systems
Radiology · 35d
Cleared Jul 13, 2000
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
K002003 · IYN
Atl Ultrasound, Inc.
Radiology · 13d
Cleared Jul 13, 2000
POCKET ULTRASONIC PACHYMETER
K993674 · IYO
Quantel Medical
Radiology · 255d
Cleared Jul 13, 2000
BRAINSCAN
K994413 · MUJ
Brainlab AG
Radiology · 197d
Cleared Jul 10, 2000
PEDIATRIC REFERENCE DATA
K001812 · KGI
Lunar Corp.
Radiology · 25d
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Jul 06, 2000
LIFERX
K001596 · LLZ
Bowdengs Technologies, LLC
Radiology · 44d
Cleared Jul 06, 2000
LUNAR REPORT GENERATOR II
K001756 · KGI
Lunar Corp.
Radiology · 27d
Cleared Jul 06, 2000
MODIFICATION TO E-SCAN
K001894 · LNH
Biosound Esaote, Inc.
Radiology · 15d
Cleared Jun 30, 2000
VSCORE WITH EKG SIGNAL GATING
K001682 · JAK
Vital Images, Inc.
Radiology · 29d
Cleared Jun 30, 2000
UNICORN MODEL SYS0630
K001888 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Jun 29, 2000
NICOLET EME LEGEND TC22
K993939 · IYN
Nicolet Biomedical
Radiology · 223d
Cleared Jun 28, 2000
XPLAN 2.1
K001700 · MUJ
Radionics, Inc.
Radiology · 23d
Cleared Jun 27, 2000
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · IZL
Shimadzu Corp.
Radiology · 42d
Cleared Jun 23, 2000
VARIS 1.4G
K001643 · IYE
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jun 22, 2000
ULTRASIM CT SYSTEM
K001088 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 79d
Cleared Jun 22, 2000
ORTHOCEPH OC100 D
K001439 · MUH
Instrumentarium Corp.
Radiology · 45d
Cleared Jun 22, 2000
NOVAC7
K990209 · IYE
Hitesys S.P.A.
Radiology · 518d