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
1537–1560 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 08, 2023
SIDDHARTH-II
K222762 · IYE
Panacea Medical Technologies Pvt. , Ltd.
Radiology · 268d
Cleared Jun 07, 2023
Ambra PACS
K231360 · LLZ
Dicom Grid Dba Ambra Health
Radiology · 28d
Cleared Jun 07, 2023
C350/C350G LCD Monitor
K231170 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 43d
Cleared Jun 06, 2023
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K223855 · QIH
Feops NV
Radiology · 165d
Cleared Jun 06, 2023
Olea S.I.A. Neurovascular V1.0
K223532 · LLZ
Olea Medical
Radiology · 195d
Cleared Jun 01, 2023
ANT-X System
K230185 · OWB
Ndr Medical Technology Pte. , Ltd.
Radiology · 129d
Cleared Jun 01, 2023
Brainomix 360 e-CTP
K223555 · LLZ
Brainomix Limited
Radiology · 185d
Cleared Jun 01, 2023
OmniTom Elite
K223447 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 198d
Cleared May 30, 2023
KBA3D
K223841 · LLZ
S.M.A.I.O
Radiology · 159d
Cleared May 30, 2023
Sonic DL
K223523 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 188d
Cleared May 30, 2023
Quicktome Software Suite
K222359 · LLZ
Omniscient Neurotechnology Pty Ltd (O8t)
Radiology · 299d
Cleared May 26, 2023
Eclipse Treatment Planning System (v18.0)
K230557 · MUJ
Varian Medical Systems, Inc.
Radiology · 87d
Cleared May 26, 2023
Pre-Sure
K230044 · LLZ
Lazarus 3D
Radiology · 140d
Cleared May 25, 2023
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care...
K223491 · QBS
Ge Medical Systems, LLC
Radiology · 185d
Cleared May 24, 2023
Avatar Medical Software V1
K222035 · LLZ
Avatar Medical
Radiology · 317d
Cleared May 23, 2023
ROSA Hip System
K231162 · LLZ
Orthosoft Inc. (d/b/a) Zimmer CAS
Radiology · 29d
Cleared May 23, 2023
ADAS 3D
K230803 · LLZ
Adas3D Medical S.L.
Radiology · 61d
Cleared May 23, 2023
uMR Omega
K230152 · LNH
Shanghai United Imaging Healthcare...
Radiology · 124d
Cleared May 23, 2023
Genius AI Detection 2.0 with CC-MLO Correlation
K230096 · QDQ
Hologic, Inc.
Radiology · 130d
Cleared May 22, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
K223839 · IYE
Varian Medical Systems, Inc.
Radiology · 151d
Cleared May 19, 2023
VirtuOst
K220402 · KGI
O.N. Diagnostics
Radiology · 462d
Cleared May 19, 2023
Autoplaque
K212758 · LLZ
Cedars-Sinai Medical Center: Aim
Radiology · 626d
Cleared May 18, 2023
uMR 570
K230758 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared May 18, 2023
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
K230723 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 63d