Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology × Cleared only ×
15,676 results
1081–1104 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 02, 2024
SMART Bun-Yo-Matic X-Ray
K240736 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jul 02, 2024
AOS Marker Seeds (SMG0242-025)
K233626 · JAQ
Alpha-Omega Services, Inc.
Radiology · 232d
Cleared Jul 01, 2024
Hyper Insight - ICH
K240353 · QAS
Sk, Inc.
Radiology · 147d
Cleared Jul 01, 2024
cNeuro cDAT
K233908 · LLZ
Combinostics OY
Radiology · 202d
Cleared Jun 28, 2024
nordicMEDiVA
K241608 · LLZ
Nordicneurolab AS
Radiology · 24d
Cleared Jun 26, 2024
Magnifico Open (100009900)
K241133 · LNH
Esaote, S.P.A.
Radiology · 63d
Cleared Jun 26, 2024
SC1 Handheld Ultrasound Imaging system (Model: SC1)
K233579 · IYO
Fcu Co., Ltd.
Radiology · 232d
Cleared Jun 26, 2024
TRIDENT Mobile Fluoroscopy System
K233380 · JAA
Dornier Medtech America
Radiology · 268d
Cleared Jun 25, 2024
VEA Align
K240582 · QIH
Eos Imaging
Radiology · 116d
Cleared Jun 21, 2024
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
K240631 · IYN
Samsung Medison Co., Ltd.
Radiology · 107d
Cleared Jun 21, 2024
O-arm O2 Imaging System
K240465 · OWB
Medtronic Navigation, Inc.
Radiology · 126d
Cleared Jun 21, 2024
See Factor CT3™
K233230 · OWB
Epica International, Inc.
Radiology · 267d
Cleared Jun 21, 2024
Medihub Prostate
K233196 · QIH
JLK, Inc.
Radiology · 267d
Cleared Jun 20, 2024
SMART Bun-Yo-Matic CT
K240642 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jun 17, 2024
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K240684 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Jun 17, 2024
MediOMx
K233331 · LLZ
Pmx, Inc.
Radiology · 262d
Cleared Jun 14, 2024
SIS System
K241083 · QIH
Surgical Information Sciences, Inc.
Radiology · 56d
Cleared Jun 14, 2024
Clarius OB AI
K233955 · IYN
Clarius Mobile Health Corp.
Radiology · 182d
Cleared Jun 13, 2024
21.3” 5MP Color LCD Display UMD5-21B01
K241499 · PGY
Acula Technology Corp.
Radiology · 16d
Cleared Jun 13, 2024
Relu Creator
K233925 · QIH
Relu BV
Radiology · 183d
Cleared Jun 13, 2024
Radiography 7300 C
K233662 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 211d
Cleared Jun 12, 2024
RS85 Diagnostic Ultrasound System
K240516 · IYN
Samsung Medison Co., Ltd.
Radiology · 110d
Cleared Jun 12, 2024
ACUSON SC2000 Diagnostic Ultrasound System
K233613 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 212d
Cleared Jun 12, 2024
ACUSON P500 Ultrasound System
K233610 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 212d