FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

Validate with FDA (Live)

Device Name

EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System

Manufacturer

Samsung Medison Co., Ltd.

Date Cleared

2026-03-27

(98 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252006

Validate with FDA (Live)

Device Name

OTTO Disinfecting Cap

Manufacturer

Icu Medical, Inc.

Date Cleared

2026-03-27

(273 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260697

Validate with FDA (Live)

Device Name

VyPlate Anterior Cervical Plate System

Manufacturer

Vy Spine, LLC

Date Cleared

2026-03-27

(23 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253625

Validate with FDA (Live)

Device Name

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Manufacturer

Canon Medical Systems Corporation

Date Cleared

2026-03-27

(129 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K251273

Validate with FDA (Live)

Device Name

Asurys Fluid Management System

Manufacturer

Boston Scientific Corporation

Date Cleared

2026-03-27

(337 days)

Product Code

HIG

Regulation Number

884.1700

Type

Traditional

Panel

Obstetrics/Gynecology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252148

Validate with FDA (Live)

Device Name

Butterfly Gestational Age Tool

Manufacturer

Butterfly Network, Inc.

Date Cleared

2026-03-27

(261 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260240

Validate with FDA (Live)

Device Name

SYMPHONY Navigation Ready Instruments

Manufacturer

Medos International SARL

Date Cleared

2026-03-27

(60 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253572

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Device Name

STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device

Manufacturer

ETHICON, Inc.

Date Cleared

2026-03-27

(130 days)

Product Code

GAW

Regulation Number

878.5010

Type

Traditional

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260746

Validate with FDA (Live)

Device Name

S-scan Open (100001800)

Manufacturer

Esaote, S.p.A.

Date Cleared

2026-03-27

(21 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253270

Validate with FDA (Live)

Device Name

Contour ProtégéAI+

Manufacturer

Mim Software, Inc.

Date Cleared

2026-03-27

(179 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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510(k) Data Aggregation