CardioMD

Basic Information

• Brand Name: CardioMD
• Primary DI: 05711665002029
• Version / Model: CardioMD Gamma Camera System
• Catalog Number: 9PMS3060
• Company Name: Ddd-Diagnostic A/S
• Labeler DUNS: 305116642
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-09
• Public Version: 5
• Public Version Date: 2019-08-22
• Public Version Status: Update
• Public Device Record Key: 572aa905-2348-449b-a159-1cf096d22e53
• Distribution End Date: 2018-07-04

Device Description

Gamma Camera System

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPS	System, Tomography, Computed, Emission	Radiology	892.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40640	Stationary gamma camera system	An assembly of static diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, crystal(s), a collimator and a set of photomultiplier tubes or photo diodes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05711665002029	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011611	000

Device Sizes

Type	Value	Unit	Text
Width	284	Centimeter
Depth	150	Centimeter
Height	150	Centimeter
Weight	815	Kilogram