Cleared Special

K210692 - DigitalDiagnost

K210692 is an FDA 510(k) clearance for DigitalDiagnost, manufactured by Philips Medical Systems Dmc GmbH. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 25-day FDA review.

K210692 · Philips Medical Systems Dmc GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
25d
Days
Class 2
Risk

K210692 is an FDA 510(k) clearance for the DigitalDiagnost. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on April 2, 2021 after a review of 25 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.

FDA 510(k) Submission Details - K210692

510(k) Number K210692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2021
Decision Date April 02, 2021
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
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 357
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K210692.
Straight Arm DDR
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Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
K203537 · Sedecal., Sa. · Feb 2021
MULTIX Impact
K203345 · Siemens Medical Solutions USA, Inc. · Jan 2021
MULTIX Impact C
K203340 · Siemens Medical Solutions USA, Inc. · Jan 2021
K210692 · DigitalDiagnost
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