DRX 2530C DETECTOR 9J2791

GUDID 60889974000078

AY-DETECTOR-PACKED-25X30

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector

• Primary Device ID: 60889974000078
• NIH Device Record Key: 5c8dfddf-ba8e-4f56-abea-464d77b835e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRX 2530C DETECTOR
• Version Model Number: DRX 2530C DETECTOR
• Catalog Number: 9J2791
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889974000078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130464

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: 8
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-16

On-Brand Devices [DRX 2530C DETECTOR]

• 60889974000795: AY-DETECTOR-2530-COMPLETE-OEM
• 60889974000078: AY-DETECTOR-PACKED-25X30
• 60889975950525: PACKED, DETECTOR, 2530 C