FDA.reportPublic FDA data

Imagio®

Primary DI
00864802000442
Brand
Imagio®
Company
Seno Medical Instruments, Inc.
Model
8100
Catalog number
8100-181-00
Device description
Transducer (OA/US Probe) Model 8100
Published
2023-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QNKOptoacoustic Imaging System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNKOptoacoustic Imaging SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200003001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200003001Imagio Breast Imaging SystemSeno Medical Instruments, Inc.2021-01-11QNK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864802000442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864802000442008648020004428648020004420864802000442

GMDN Terms#

Term, Definition table
TermDefinition
Optoacoustic/ultrasound imaging systemA mobile assembly of electrically-powered devices intended for imaging and analysis of soft-tissue and soft-tissue vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging. It includes a processing unit with a monitor, controls, and integrated software, and a dedicated laser-emitting extracorporeal ultrasound transducer. Pulsed near-infrared laser light of various wavelengths is emitted and the associated acoustic feedback (photoacoustic effect) provides complementary information regarding tissue composition/functionality based on the presence of endogenous chromophores, such as haemoglobin; this photoacoustic data can be overlaid on the associated US image.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-978-8835service@senomedical.com

Regulatory Flags#

DUNS number
615062499
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864802000459Imagio®91009100-000-022023-07-07
00864802000466Imagio®85008500-185-002023-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864802000459Imagio®Seno Medical Instruments, Inc.QNK2023-07-07