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 ×
15,695 results
1537–1560 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 16, 2023
IB Lab LAMA
K223646 · QIH
Ib Lab GmbH
Radiology · 192d
Cleared Jun 16, 2023
DeepCatch
K223556 · QIH
Medical IP Co., Ltd.
Radiology · 200d
Cleared Jun 13, 2023
CAC Software
K230112 · JAK
Imbio, Inc.
Radiology · 147d
Cleared Jun 09, 2023
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K230768 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 81d
Cleared Jun 09, 2023
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
K230728 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 85d
Cleared Jun 09, 2023
Orthopantomograph™ OP 3D LX
K230505 · OAS
Palodex Group OY
Radiology · 105d
Cleared Jun 09, 2023
CT Perfusion V1.0
K223091 · LLZ
Olea Medical
Radiology · 252d
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