Konica Minolta SW (PACS) Exa

GUDID 00817100020193

EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.

KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 00817100020193
• NIH Device Record Key: befc67c1-dfee-4b4c-b48a-9c2b7cb98516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Konica Minolta SW (PACS) Exa
• Version Model Number: EXA 01-04-000
• Company DUNS: 080269345
• Company Name: KONICA MINOLTA MEDICAL IMAGING U.S.A., 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com
• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com
• Phone: 1-800-366-5343
• Email: HTICSupport@konicaminolta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817100020193 [Primary]

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: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-24

Devices Manufactured by KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

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• 00817100020315 - RF 14X17 Sensor Panel: 2019-05-07 RF 14X17 Sensor Panel-R
• 00817100020483 - RF 11X14 Sensor Panel: 2019-05-07 RF 11X14 Sensor Panel -R/-L
• 00817100020513 - RF 11X14 Sensor Panel: 2019-05-07 DR-PANEL-LT1114-L / R
• 00817100020193 - Konica Minolta SW (PACS) Exa: 2019-02-21EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.
• 00817100020193 - Konica Minolta SW (PACS) Exa: 2019-02-21 EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound s
• 00817100020209 - Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad: 2019-02-21 Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultraso
• 00817100020216 - 17X17 CsI Fixed Flat Panel Detector: 2019-02-21 IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)
• 00817100020223 - 17X17 GOS Fixed Flat Panel Detector: 2019-02-21 IR 17X17 GOS Fixed Flat Panel Detector (-R or -L)