x-mind dc 5.92.15107

GUDID D804592151070

x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.

DE GÖTZEN SRL

Stationary intraoral dental x-ray system, digital

• Primary Device ID: D804592151070
• NIH Device Record Key: dbaf50b6-66da-40a8-86c8-f0f658b87fa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: x-mind dc
• Version Model Number: DC X-MIND 115V,SHORT CONE,TOP 40 (16” - 40,64cm)
• Catalog Number: 5.92.15107
• Company DUNS: 433051802
• Company Name: DE GÖTZEN SRL
• 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: true
• 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: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com
• Phone: +390331376760
• Email: imaging.italysupport@acteongroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 85 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D804592151070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231055

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-12
• Device Publish Date: 2025-09-04

On-Brand Devices [x-mind dc]

• D804592151030: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592159900: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592159850: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151130: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804593151080: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151190: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151180: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151170: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151120: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151110: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151100: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151090: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151080: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151070: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151020: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151010: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra
• D804592151000: x-mind dc is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral ra