CR Reader

GUDID 00817100020360

AF CR Reader-R

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

Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray

• Primary Device ID: 00817100020360
• NIH Device Record Key: 7f8dc4c1-f9ba-453a-8551-ea874a9db0ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CR Reader
• Version Model Number: CR30
• 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
• 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
• 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
• 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
• 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
• 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	00817100020360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062223

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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

On-Brand Devices [CR Reader]

• 00817100020391: CR Reader-R
• 00817100020360: AF CR Reader-R