Cleared Special

K081836 - CARESTREAM DR LONG LENGTH IMAGING SYSTE...

K081836 is an FDA 510(k) clearance for CARESTREAM DR LONG LENGTH IMAGING SYSTE..., manufactured by Carestream Health, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 30-day FDA review.

K081836 · Carestream Health, Inc. · Radiology device
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Jul 2008
Decision
30d
Days
Class 2
Risk

K081836 is an FDA 510(k) clearance for the CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on July 30, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Carestream Health, Inc. devices

FDA 510(k) Submission Details - K081836

510(k) Number K081836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2008
Decision Date July 30, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPR System, X-ray, Stationary

All 189
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