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

K Number

K253689

Validate with FDA (Live)

Device Name

syngo Dynamics (VA41F)

Manufacturer

Siemens Healthcare GmbH

Date Cleared

2026-04-10

(140 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K260082

Validate with FDA (Live)

Device Name

TRIOS Dx (R1)

Manufacturer

3Shape TRIOS A/S

Date Cleared

2026-04-10

(88 days)

Product Code

SHQ

Regulation Number

N/A

Type

Traditional

Panel

Dental

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K252548

Validate with FDA (Live)

Device Name

AI-Rad Companion Organs RT

Manufacturer

Siemens Healthcare GmbH

Date Cleared

2026-04-10

(240 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K260090

Validate with FDA (Live)

Device Name

SMART Osteotomy System

Manufacturer

Actis Medical Pty., Ltd.

Date Cleared

2026-04-10

(88 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K253777

Validate with FDA (Live)

Device Name

Ascblue (8010)

Manufacturer

Ascblue Corporation

Date Cleared

2026-04-10

(135 days)

Product Code

GEI

Regulation Number

878.4400

Type

Traditional

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K253926

Validate with FDA (Live)

Device Name

Diacore

Manufacturer

ShenB Co., Ltd.

Date Cleared

2026-04-10

(123 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K253361

Validate with FDA (Live)

Device Name

Teleport Glide Microcatheter

Manufacturer

OrbusNeich Medical (Shenzhen) Co., Ltd.

Date Cleared

2026-04-10

(192 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K254004

Validate with FDA (Live)

Device Name

VRNT

Manufacturer

Cognifisense, Inc.

Date Cleared

2026-04-10

(116 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K252190

Validate with FDA (Live)

Device Name

DeepBT Detector-Plus

Manufacturer

Aitewan Biomedical Technology, Inc.

Date Cleared

2026-04-10

(270 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K253930

Validate with FDA (Live)

Device Name

Overjet Iris Intelligent Imaging System

Manufacturer

Overjet, Inc.

Date Cleared

2026-04-10

(122 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

Search Results

510(k) Data Aggregation