PHOT-X IIs Model 505 AR-55WKCNJ1

GUDID 04952195250424

PHOT-X IIS 505 WK with 40"Arm

TAKARA-BELMONT CO., LTD.

Stationary intraoral dental x-ray system, analogue

• Primary Device ID: 04952195250424
• NIH Device Record Key: a01838c5-96b1-4f43-a270-d50596061513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHOT-X IIs Model 505
• Version Model Number: 505
• Catalog Number: AR-55WKCNJ1
• Company DUNS: 690540349
• Company Name: TAKARA-BELMONT CO., LTD.
• Device Count: 1
• DM Exempt: true
• 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: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04952195250424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141293

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [PHOT-X IIs Model 505]

• 04952195280384: PHOT-X IIS 505 WK with 26"Arm LCD Subcontroller
• 04952195278541: PHOT-X IIS 505 WK with 12"Arm LCD Subcontroller
• 04952195278534: PHOT-X IIS 505 WK with 40"Arm LCD Subcontroller
• 04952195277063: PHOT-X IIS 505 WK with 20"Arm LCD Subcontroller
• 04952195277056: PHOT-X IIS 505 WK with 31"Arm LCD Subcontroller
• 04952195250424: PHOT-X IIS 505 WK with 40"Arm
• 04952195249213: PHOT-X IIS 505 WK with 31"Arm
• 04952195248247: PHOT-X IIS 505 WK with 20"Arm
• 04952195196258: PHOT-X IIS 505 WK with 26"Arm
• 04952195142248: PHOT-X IIS 505 WK with 12"Arm