IMAGE DIAGNOSTICS INC

Basic Information

• Brand Name: IMAGE DIAGNOSTICS INC
• Primary DI: 00850977007423
• Version / Model: 100HT
• Catalog Number: A100-1708
• Company Name: IMAGE DIAGNOSTICS, INC.
• Labeler DUNS: 608235214
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: bb172fe9-fba9-4a61-98d5-67e13be4297c
• Distribution End Date: 2020-03-16

Device Description

IDI,TABLE,TILT TABLETOP MOVEMENT,BARIATRIC SWALLOW-IMAGING,ASPECT HT,120V,#A100-1708

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	00850977007423	GS1

Customer Contacts

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