Cleared Traditional

K121345 - SR SUITE 1.0

K121345 is an FDA 510(k) clearance for SR SUITE 1.0, manufactured by Halifax Biomedical, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K121345 · Halifax Biomedical, Inc. · Radiology device
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Jun 2012
Decision
28d
Days
Class 2
Risk

K121345 is an FDA 510(k) clearance for the SR SUITE 1.0. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Halifax Biomedical, Inc. (Naples, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 28 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Halifax Biomedical, Inc. devices

FDA 510(k) Submission Details - K121345

510(k) Number K121345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2012
Decision Date June 01, 2012
Days to Decision 28 days
Submission Type Traditional
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 262
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