Cleared Traditional

K951734 - LUMIX 70B

K951734 is an FDA 510(k) clearance for LUMIX 70B, manufactured by Emix U.S.A., Inc.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K951734 · Emix U.S.A., Inc. · Radiology device
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Jul 1995
Decision
97d
Days
Class 2
Risk

K951734 is an FDA 510(k) clearance for the LUMIX 70B. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Emix U.S.A., Inc. (King Of Prussia, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Emix U.S.A., Inc. devices

FDA 510(k) Submission Details - K951734

510(k) Number K951734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1995
Decision Date July 20, 1995
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 - EAP Unit, X-ray, Intraoral

All 15
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K951734.
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PORTARAY
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