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
10993–11016 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 17, 1996
INTRACAVITY TRANSDUCERS
K953716 · ITX
Biosound, Inc.
Radiology · 252d
Cleared Apr 17, 1996
IMAGEFUSION
K960071 · LLZ
Radionics Software Applications, Inc.
Radiology · 103d
Cleared Apr 17, 1996
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382 · LMD
Eastman Kodak Company
Radiology · 83d
Cleared Apr 15, 1996
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
K945957 · IYN
Kleinfeld, Kaplan and Becker
Radiology · 496d
Cleared Apr 15, 1996
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
K950972 · JAK
Toshiba America Medical Systems, In.C
Radiology · 410d
Cleared Apr 15, 1996
OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
K951994 · IYO
Olympus America, Inc.
Radiology · 353d
Cleared Apr 12, 1996
BIOSENSOR BIDOP VASCULAR TEST SYSTEM
K943338 · JAF
Biosensor Corp.
Radiology · 640d
Cleared Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954353 · LNH
General Electric Co.
Radiology · 207d
Cleared Apr 12, 1996
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K954354 · LNH
General Electric Co.
Radiology · 207d
Cleared Apr 12, 1996
RTI MEDICAL
K954567 · LMD
Radiology Telenetwork Intl.
Radiology · 196d
Cleared Apr 12, 1996
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
K955251 · OXO
Imaging Services, Inc.
Radiology · 149d
Cleared Apr 09, 1996
PEACOCK PLAN
K940663 · IYE
Nomos Corp.
Radiology · 781d
Cleared Apr 08, 1996
PINNACLE3 APEX
K951581 · IYE
Adac Laboratories
Radiology · 370d
Cleared Apr 08, 1996
LAST IMAGE HOLD
K951942 · LMB
Insight Systems
Radiology · 348d
Cleared Apr 08, 1996
DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A
K953530 · IYO
Biosound, Inc.
Radiology · 256d
Cleared Apr 08, 1996
HP SONOS 100CF ULTRASOUND IMAGING SYSTEM
K955327 · IYN
Hewlett-Packard Co.
Radiology · 140d
Cleared Apr 08, 1996
INSTATRAK
K960330 · LLZ
Visualization Technology, Inc.
Radiology · 75d
Cleared Apr 07, 1996
PHILIPS SITE VIEW WORKSTATION
K960809 · LMD
Philips Medical Systems North...
Radiology · 39d
Cleared Apr 05, 1996
SIEMENS Q64XXX
K950157 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 444d
Cleared Apr 05, 1996
SMITH S-100 TIME & TEMPERATURE CONTROL
K955825 · EGY
Smith Companies Dental Products
Radiology · 101d
Cleared Apr 04, 1996
TIGERSCAN/TIGERVIEW
K955237 · LMB
Tau Corp.
Radiology · 142d
Cleared Apr 03, 1996
PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED...
K960635 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Apr 03, 1996
XRE COLLIMATOR
K960998 · IZW
Xre Corp.
Radiology · 22d
Cleared Mar 29, 1996
SBDX MOBILE FLUOROSCOPY SYSTEM
K953113 · JAA
Cardiac Mariners, Inc.
Radiology · 270d