Cleared Traditional

K130567 - DR LONG LENGTH IMAGING SOFTWARE (FDA 510(k) Clearance)

K130567 · Carestream Health, Inc. · Radiology device

Jun 2013

Decision

99d

Days

Class 2

Risk

K130567 is an FDA 510(k) clearance for the DR LONG LENGTH IMAGING SOFTWARE. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on June 11, 2013, 99 days after receiving the submission on March 4, 2013.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K130567 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 04, 2013
Decision Date	June 11, 2013
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF