EDDA TECHNOLOGY

GUDID 00868466000206

IQQA-Chest is an image analysis CAD software used during the review of digital chest radiographic images.

EDDA TECHNOLOGY, INC.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 00868466000206
• NIH Device Record Key: 3fcec8ac-cbba-4ddd-b5ed-262356be988b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDDA TECHNOLOGY
• Version Model Number: IQQA-Chest
• Company DUNS: 782779701
• Company Name: EDDA TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com
• Phone: 1-609-919-9889
• Email: support@edda-tech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868466000206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042408

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-20

On-Brand Devices [EDDA TECHNOLOGY]

• 00868466000237: IQQA-Guide is intended for intra-operative guidance for surgical procedures
• 00868466000220: IQQA-BodyImaging is an image analysis software for reviewing body imaging studies (including tho
• 00868466000213: IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT and MR
• 00868466000206: IQQA-Chest is an image analysis CAD software used during the review of digital chest radiographi
• 00868466000244: IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT scanner