FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

OPTIMAL IMAGING SYSTEMS, INC.

Date Cleared

2000-04-11

(63 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

OPTIMAL IMAGING SYSTEMS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

Ask a Question

Ask a specific question about this device

K Number

Device Name

OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

OPTIMAL IMAGING SYSTEMS, INC.

Date Cleared

2000-02-24

(49 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

OPTIMAL IMAGING SYSTEMS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

Ask a Question

Ask a specific question about this device

Page 1 of 1