Owandy-RX DC 5.92.15614

GUDID 03760262653419

Owandy-RX 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.

OWANDY RADIOLOGY

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 03760262653419
• NIH Device Record Key: c7deed1a-b687-41fb-8d2a-d5ba41bbc2f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Owandy-RX DC
• Version Model Number: DC OWANDY 115V VET,SHORT CONE,TOP 80 (16” - 40,64c
• Catalog Number: 5.92.15614
• Company DUNS: 265612235
• Company Name: OWANDY RADIOLOGY
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760262653419 [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: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [Owandy-RX DC]

• 03760262652993: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653426: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653419: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653402: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653396: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653389: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653372: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653334: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653327: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653075: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653068: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653051: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653044: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653020: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653013: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral
• 03760262653006: Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral