Cleared Traditional

K070713 - IMPLANT LOCATION SOFTWARE-T

K070713 is an FDA 510(k) clearance for IMPLANT LOCATION SOFTWARE-T, manufactured by Tactile Technologies, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K070713 · Tactile Technologies, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
49d
Days
Class 2
Risk

K070713 is an FDA 510(k) clearance for the IMPLANT LOCATION SOFTWARE-T. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Tactile Technologies, Ltd. (Rechovot, IL). The FDA issued a Cleared decision on May 2, 2007 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K070713

510(k) Number K070713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2007
Decision Date May 02, 2007
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. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K070713.
LMS-LUNG/TRACK
K070868 · Median Technologies · May 2007
MYRIAN
K071000 · Intrasense · May 2007
INTERWORKS
K070755 · Avreo, Inc. · May 2007
NIO COLOR 3MP AND MDNC 3120
K070726 · Barcoview, Medical Imaging Systems · May 2007
SAPHENEIA CLARITY
K063391 · Sapheneia Commercial Products AB · Apr 2007
DICOMPACS, MODEL 5
K070618 · Oehm Und Rehbein GmbH · Apr 2007
K070713 · IMPLANT LOCATION SOFTWARE-T
Download PDF FDA Summary Tactile Technologies,…