SmartGrid

Solid State X-ray Imager (flat Panel/digital Imager)

Carestream Health, Inc.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Smartgrid.

Pre-market Notification Details

• Device ID: K180667
• 510k Number: K180667
• Device Name: SmartGrid
• Classification: Solid State X-ray Imager (flat Panel/digital Imager)
• Applicant: Carestream Health, Inc. 150 Verona Street Rochester, NY 14608
• Contact: Diane Koetter
• Correspondent: Diane Koetter; Carestream Health, Inc. 150 Verona Street Rochester, NY 14608
• Product Code: MQB
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-14
• Decision Date: 2018-04-13
• Summary: summary