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
4657–4680 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 01, 2015
ICIS View
K143397 · LLZ
Agfa Healthcare N.V.
Radiology · 187d
Cleared May 27, 2015
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
K151134 · PGY
Jvckenwood Corporation
Radiology · 28d
Cleared May 27, 2015
IntelePACS
K150707 · LLZ
Intelerad Medical Systems Incorporated
Radiology · 69d
Cleared May 26, 2015
Centricity Universal Viewer
K150420 · LLZ
Ge Healthcare
Radiology · 97d
Cleared May 22, 2015
VentriPoint Medical System
K150628 · IYN
Ventripoint, Inc.
Radiology · 72d
Cleared May 22, 2015
Fine Structure Analysis(fineSA)
K150069 · LLZ
Acuitas Medical , Ltd.
Radiology · 129d
Cleared May 22, 2015
SPINEDESIGN Spine Surgery Planning (Software Application)
K142648 · LLZ
Medtronic Sofamor Danek USA, Inc.
Radiology · 247d
Cleared May 20, 2015
Dose Calculator
K150848 · IYE
Sun Nuclear Corporation
Radiology · 50d
Cleared May 20, 2015
E-App
K142719 · JAQ
Gc Medtech, LLC
Radiology · 239d
Cleared May 20, 2015
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
K141900 · MUJ
Eckert & Ziegler Bebig GmbH
Radiology · 310d
Cleared May 18, 2015
syngo.CT Dental
K150785 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared May 15, 2015
ZONARE ZS3 Diagnostic Ultrasound System
K151175 · IYN
Zonare Medical Systems, Inc.
Radiology · 14d
Cleared May 15, 2015
Active Breathing Coordinator
K151097 · IYE
Aktina Medical Corporation
Radiology · 21d
Cleared May 15, 2015
.decimal Astroid Dosimetry App
K150547 · MUJ
.Decimal, Inc.
Radiology · 73d
Cleared May 15, 2015
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways
K143294 · JAK
Toshibamedical Systems Corporation
Radiology · 179d
Cleared May 14, 2015
Planmed Verity
K143435 · OAS
Planmed OY
Radiology · 164d
Cleared May 12, 2015
syngo.CT Lung CAD
K143196 · OEB
Siemens AG Medical Solutions
Radiology · 187d
Cleared May 09, 2015
Terason uSmart3200T Ultrasound System
K150533 · IYN
Teratech Corp.
Radiology · 68d
Cleared May 08, 2015
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
K151007 · PGY
Jvckenwood Corporation
Radiology · 23d
Cleared May 08, 2015
Jumong Series
K150816 · KPR
Sg Healthcare Co, Ltd.
Radiology · 42d
Cleared May 08, 2015
VitalBeam
K150706 · IYE
Varian Medical Systems, Inc.
Radiology · 51d
Cleared May 08, 2015
VariSeed 9.0
K150636 · KXK
Varian Medical Systems, Inc.
Radiology · 58d
Cleared May 08, 2015
Touch Ultrasound
K150342 · IYO
Carestream Health, Inc.
Radiology · 86d
Cleared May 08, 2015
ORTHOPHOS SL
K150217 · OAS
Sirona Dental Systems GmbH
Radiology · 98d