Cleared Traditional

K122016 - REXTAR, REXTAR LCD

K122016 is an FDA 510(k) clearance for REXTAR, manufactured by Meta Biomed, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K122016 · Meta Biomed, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
234d
Days
Class 2
Risk

K122016 is an FDA 510(k) clearance for the REXTAR, REXTAR LCD. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Meta Biomed, Inc. (Mt. Airy, US). The FDA issued a Cleared decision on March 1, 2013 after a review of 234 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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.

FDA 510(k) Submission Details - K122016

510(k) Number K122016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2012
Decision Date March 01, 2013
Days to Decision 234 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
127d slower than avg
Panel avg: 107d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 175
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K122016.
ENDOGRAPH DC
K130109 · Villa Sistemi Medicali S.P.A. · Aug 2013
REXTAR X
K132041 · Meta Biomed, Inc. · Jul 2013
PORTABLE X-RAY SYSTEM
K122124 · Osstem Implant Co., Ltd. · May 2013
VEX-S 100W INTRAORAL X-RAY SYSTEM
K123493 · VATECH Co., Ltd. · Dec 2012
DENTAL X-RAY Z70 (W)
K122582 · Denterprise International, Inc. · Dec 2012
AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
K111330 · Skanray Technologies · May 2011