Cleared Abbreviated

K001888 - UNICORN MODEL SYS0630

K001888 is an FDA 510(k) clearance for UNICORN MODEL SYS0630, manufactured by Danish Diagnostic Development A/S. The device is a Class 2 Radiology device with product code KPS cleared through the Abbreviated 510(k) pathway after a 15-day FDA review.

K001888 · Danish Diagnostic Development A/S · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
15d
Days
Class 2
Risk

K001888 is an FDA 510(k) clearance for the UNICORN MODEL SYS0630. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Danish Diagnostic Development A/S (2970 Horshom, DK). The FDA issued a Cleared decision on June 30, 2000 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K001888

510(k) Number K001888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2000
Decision Date June 30, 2000
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 Consultant

Underwriters Laboratories, Inc.
R. KENT DONOHUE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 463
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K001888.
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K001888 · UNICORN MODEL SYS0630
Download PDF FDA Summary Danish Diagnostic Dev…