M'Ath PACS

Basic Information

• Brand Name: M'Ath PACS
• Primary DI: 03760264690115
• Version / Model: 3.2.1
• Company Name: I M T
• Labeler DUNS: 266778164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-24
• Public Version: 1
• Public Version Date: 2019-10-02
• Public Version Status: New
• Public Device Record Key: c2f839bc-a63e-44be-b919-39b62322c7a0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59086	Cardiovascular risk evaluation interpretive software	An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization). It typically combines some of the following data: patient demographics, physical measurements, symptoms, medical history, results of the qualitative/quantitative clinical specimen in vitro diagnostic (IVD) tests. It typically creates a risk score or probability that may be used to guide patient management.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760264690115	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K040686	000