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
1897–1920 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 25, 2022
Viz SDH
K220439 · QAS
Viz. Ai, Inc.
Radiology · 159d
Cleared Jul 22, 2022
PreXion3D Explorer PRO
K221525 · OAS
Prexion Corporation
Radiology · 57d
Cleared Jul 22, 2022
10HQ701G-B
K221461 · MQB
Lg Electronics.Inc
Radiology · 64d
Cleared Jul 22, 2022
14HQ701G-B
K221394 · MQB
Lg Electronics.Inc
Radiology · 70d
Cleared Jul 22, 2022
EchoPAC Software Only, EchoPAC Plug-in
K220940 · QIH
GE Medical Systems Ultrasound and...
Radiology · 113d
Cleared Jul 22, 2022
Vivid E80, Vivid E90, Vivid E95
K220882 · IYN
Ge Medical Systems Ultrasound And
Radiology · 119d
Cleared Jul 22, 2022
AI4CMR v1.0
K220624 · LLZ
Ai4medimaging Medical Solutions S.A.
Radiology · 141d
Cleared Jul 22, 2022
FX SPS
K213922 · LLZ
Pixee Medical
Radiology · 219d
Cleared Jul 20, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K221512 · MQB
Vieworks Co., Ltd.
Radiology · 57d
Cleared Jul 20, 2022
Libby Echo:Prio
K220956 · QIH
Dyad Medical, Inc.
Radiology · 110d
Cleared Jul 20, 2022
AutoSeg
K220039 · LLZ
Ai Medic, Inc.
Radiology · 196d
Cleared Jul 19, 2022
ARTIS icono (Ceiling Configuration)
K221516 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jul 19, 2022
BrainInsight
K220815 · QIH
Hyperfine, Inc.
Radiology · 120d
Cleared Jul 18, 2022
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
K221803 · IZL
Sedecal., Sa.
Radiology · 26d
Cleared Jul 18, 2022
Vivid iq
K221148 · IYN
GE Medical Systems Ultrasound &...
Radiology · 89d
Cleared Jul 18, 2022
Vivid T8, Vivid T9
K221147 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Jul 18, 2022
Planmed Clarity 2D, Planmed Clarify S
K211720 · MUE
Planmed OY
Radiology · 409d
Cleared Jul 15, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K221876 · MQB
Canon, Inc.
Radiology · 17d
Cleared Jul 15, 2022
Vivid S60N, Vivid S70N
K220619 · IYN
GE Medical Systems Ultrasound and...
Radiology · 134d
Cleared Jul 13, 2022
syngo.CT Extended Functionality
K221727 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jul 13, 2022
17HQ701G-B
K221434 · MQB
Lg Electronics.Inc
Radiology · 57d
Cleared Jul 12, 2022
NAEOTOM Alpha, Scan&GO Software
K220814 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Jul 12, 2022
Veuron-Brain-mN1
K203279 · LNH
Heuron Co., Ltd.
Radiology · 613d
Cleared Jul 10, 2022
MINE ALNU (Model: Mine 2.1)
K213405 · IZL
Hdt Co., Ltd.
Radiology · 264d