Cleared Traditional

K180765 - Televere Podiatry X-Ray System HF

K180765 is the FDA 510(k) clearance for Televere Podiatry X-Ray System HF by Televere Systems, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K180765 · Televere Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
28d
Days
Class 2
Risk

K180765 is an FDA 510(k) clearance for the Televere Podiatry X-Ray System HF. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Televere Systems, Inc. (Arnold, US). The FDA issued a Cleared decision on April 20, 2018 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 Televere Systems, Inc. devices

Submission Details

510(k) Number K180765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2018
Decision Date April 20, 2018
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.

Device Classification

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 Consultant

Technology and Business Law Advisors, LLC
Robert Bakin

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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K180765.
Ysio Max
K181279 · Siemens Medi Cal Solutions, Inc. · Jun 2018
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
K180543 · Samsung Electronics Co., Ltd. · May 2018
LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
K180663 · Livermoretech, Inc. · May 2018
RADspeed fit
K173517 · Shimadzu Corporation · Mar 2018
Amrad Medical AAU Digital Radiography System
K173823 · Summit Industries, LLC · Feb 2018
uDR 780i
K173953 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2018