Cleared Traditional

K150457 - AlfaSight 9000 Thermographic System

K150457 is an FDA 510(k) clearance for AlfaSight 9000 Thermographic System, manufactured by Alfa Thermodiagnostics, Inc.. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K150457 · Alfa Thermodiagnostics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
49d
Days
Class 1
Risk

K150457 is an FDA 510(k) clearance for the AlfaSight 9000 Thermographic System. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Alfa Thermodiagnostics, Inc. (Aptos, US). The FDA issued a Cleared decision on April 10, 2015 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - 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.

FDA 510(k) Submission Details - K150457

510(k) Number K150457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2015
Decision Date April 10, 2015
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

LHQ Device Classification - Class 1, General Controls

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Hogan Lovells US LLP
John J Smith

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.

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All 33
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K150457 · AlfaSight 9000 Thermographic System
Download PDF FDA Summary Alfa Thermodiagnostic…