Cleared Traditional

K213760 - ABMD Software

K213760 is an FDA 510(k) clearance for ABMD Software, manufactured by HeartLung Corporation. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K213760 · HeartLung Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
240d
Days
Class 2
Risk

K213760 is an FDA 510(k) clearance for the ABMD Software. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by HeartLung Corporation (Torrance, US). The FDA issued a Cleared decision on July 29, 2022 after a review of 240 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - 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 HeartLung Corporation devices

FDA 510(k) Submission Details - K213760

510(k) Number K213760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2021
Decision Date July 29, 2022
Days to Decision 240 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
133d slower than avg
Panel avg: 107d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGI Device Classification - Class 2, Special Controls

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
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 - KGI Densitometer, Bone

All 44
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