IMAGE DIAGNOSTICS INC

Basic Information

• Brand Name: IMAGE DIAGNOSTICS INC
• Primary DI: 00850977007164
• Version / Model: ISR G2
• Catalog Number: A100-2641
• Company Name: IMAGE DIAGNOSTICS, INC.
• Labeler DUNS: 608235214
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-18
• Public Version: 3
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 6db0b17f-218c-4893-bb67-2d979b451865
• Distribution End Date: 2018-04-03

Device Description

IDI,TABLE,VERT.-TILT-ROLL-HORIZ. TABLETOP MOVEMENT,VASCULAR-INTERVENTIONAL-IMAGING,ASPECT ISR G2,230V,WITHOUT MINI ACC'Y RAILS,METRIC ACC'Y RAILS,#A100-2641

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: Yes
• 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
IXR	Table, Radiographic, Tilting	Radiology	892.1980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40680	Multi-purpose diagnostic imaging table	An electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850977007164	GS1

Customer Contacts

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