PEDRA PEDRA-1417FC

GUDID 08800099500038

Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)

Radisen Co., Ltd.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector

• Primary Device ID: 08800099500038
• NIH Device Record Key: 08f5245c-7bec-4798-b717-dce7d03cd465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEDRA
• Version Model Number: 1417FC
• Catalog Number: PEDRA-1417FC
• Company DUNS: 694770428
• Company Name: Radisen 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800099500038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221144

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-23
• Device Publish Date: 2023-11-15

On-Brand Devices [PEDRA]

• 08800099500090: Solid State X-ray Imager (Flat Panel / Digital Imager)
• 08800099500083: Solid State X-ray Imager (Flat Panel / Digital Imager)
• 08800099500069: Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500052: Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500045: Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500038: Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500021: Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500014: Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500007: Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)