2020 Imaging Podiatry System HF PXS-710

GUDID 00817100020148

X-Ray System, Podiatry DR Ready (70kVp,10mA).

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

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00817100020148
• NIH Device Record Key: b1a0df74-6c0d-490a-88f7-cb645e4180b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2020 Imaging Podiatry System HF
• Version Model Number: XR410i
• Catalog Number: PXS-710
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: 1-800-366-5343
• 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	00817100020148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133959

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2018-07-06
• Device Publish Date: 2016-09-24

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