Q-RAD System 1019264

GUDID 60889971019264

Q-RAD SYSTEM/QGV-40-R10-T140

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 60889971019264
• NIH Device Record Key: 536680ff-7acc-41be-985a-c63a2ba52625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-RAD System
• Version Model Number: Q-RAD System
• Catalog Number: 1019264
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889971019264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011486

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: 4
• Public Version Date: 2019-01-31
• Device Publish Date: 2016-09-16

On-Brand Devices [Q-RAD System]

• 60889976574621: Q-RAD SYSTEM/QG-500-4-R10-T740
• 60889976574614: Q-RAD SYSTEM/QG-500-4-R10-T080
• 60889976574607: Q-RAD SYSTEM/QG-500-2-R10-T740
• 60889976574591: Q-RAD SYSTEM/QG-500-2-R10-T080
• 60889976574584: Q-RAD SYSTEM/QG-500-3-R10-T740
• 60889976574577: Q-RAD SYSTEM/QG-500-3-R10-T080
• 60889976573112: Q-RAD SYSTEM/QG-50-R10-T740
• 60889976573105: Q-RAD SYSTEM/QG-50-4-R10-T740
• 60889976573099: Q-RAD SYSTEM/QG-50-2-R10-T740
• 60889976573082: Q-RAD SYSTEM/QG-40-4-R10-T740
• 60889976573075: Q-RAD SYSTEM/QG-40-4-R10-T080
• 60889976573068: Q-RAD SYSTEM/QG-40-3-R10-T740
• 60889976573051: Q-RAD SYSTEM/QG-40-3-R10-T080
• 60889976573044: Q-RAD SYSTEM/QG-40-2-R10-T740
• 60889976573037: Q-RAD SYSTEM/QG-40-2-R10-T080
• 60889976573020: Q-RAD SYSTEM/QG-40-1-R10-T740
• 60889976573013: Q-RAD SYSTEM/QG-40-1-R10-T080
• 60889976573006: Q-RAD SYSTEM/QG-400-4-R10-T080
• 60889976572993: Q-RAD SYSTEM/QG-400-3-R10-T080
• 60889976572986: Q-RAD SYSTEM/QG-400-2-R10-T080
• 60889976572979: Q-RAD SYSTEM/QG-400-1-R10-T080
• 60889976572962: Q-RAD SYSTEM/QG-320-4-R10-T140
• 60889976572955: Q-RAD SYSTEM/QG-320-3-R10-T140
• 60889976572948: Q-RAD SYSTEM/QG-320-2-R10-T140
• 60889976572931: Q-RAD SYSTEM/QG-320-1-R10-T140
• 60889976572924: Q-RAD SYSTEM/QG-80-R10-T920V
• 60889976572917: Q-RAD SYSTEM/QG-80-R10-T600
• 60889976572900: Q-RAD SYSTEM/QG-65-R10-T920V
• 60889976572894: Q-RAD SYSTEM/QG-65-R10-T600
• 60889976572887: Q-RAD SYSTEM/QG-65-R10-T140
• 60889976572870: Q-RAD SYSTEM/QG-50-R10-T920V
• 60889976572863: Q-RAD SYSTEM/QG-50-R10-T600
• 60889976572856: Q-RAD SYSTEM/QG-50-R10-T140
• 60889976572849: Q-RAD SYSTEM/QG-50-4-R10-T920V
• 60889976572832: Q-RAD SYSTEM/QG-50-4-R10-T600
• 60889976572825: Q-RAD SYSTEM/QG-50-4-R10-T140
• 60889976572818: Q-RAD SYSTEM/QG-50-2-R10-T920V
• 60889976572801: Q-RAD SYSTEM/QG-50-2-R10-T600
• 60889976572795: Q-RAD SYSTEM/QG-50-2-R10-T140
• 60889976572788: Q-RAD SYSTEM/QG-40-4-R10-T600
• 60889976572771: Q-RAD SYSTEM/QG-40-4-R10-T140
• 60889976572764: Q-RAD SYSTEM/QG-40-3-R10-T600
• 60889976572757: Q-RAD SYSTEM/QG-40-3-R10-T140
• 60889976572740: Q-RAD SYSTEM/QG-40-2-R10-T600
• 60889976572733: Q-RAD SYSTEM/QG-40-2-R10-T140
• 60889976572726: Q-RAD SYSTEM/QG-40-1-R10-T600
• 60889976572719: Q-RAD SYSTEM/QG-40-1-R10-T140
• 60889976571705: Q-RAD SYSTEM/QG-500-4-R10-T600
• 60889976571699: Q-RAD SYSTEM/QG-500-4-R10-T140
• 60889976571682: Q-RAD SYSTEM/QG-500-2-R10-T600