FDA.reportPublic FDA data

ImaCor Inc.

Primary DI
00861589000115
Brand
ImaCor Inc.
Company
IMACOR INC
Model
EVO 1
Device description
Ultrasound Machine for use with ClariTEE probe
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861589000115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861589000115008615890001158615890001150861589000115

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6312557183rlanzillotto@dukal.com

Regulatory Flags#

DUNS number
604116553
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861589000139ImaCorZHH2022-09-08
00861589000207ImaCor Inc.EVO 12017-02-10
00861589000108ClariTEE ClariTEECLT-0102016-12-10
00086158900201ImaCor Inc.EVO 12017-02-10

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Primary DI, Brand, Company table
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