Cleared Traditional

K080064 - FLAATZ 750

K080064 is an FDA 510(k) clearance for FLAATZ 750, manufactured by Drtech Corp.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K080064 · Drtech Corp. · Radiology device
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Jan 2008
Decision
13d
Days
Class 2
Risk

K080064 is an FDA 510(k) clearance for the FLAATZ 750. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Drtech Corp. (Seongnam-Shi, Gyeonggi-Do, KR). The FDA issued a Cleared decision on January 23, 2008 after a review of 13 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.

FDA 510(k) Submission Details - K080064

510(k) Number K080064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2008
Decision Date January 23, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 423
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