Cleared Traditional

ABMD Software

K213760 · HeartLung Corporation · Radiology
Jul 2022
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K213760 is an FDA 510(k) clearance for the ABMD Software, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by HeartLung Corporation (Torrance, US). The FDA issued a Cleared decision on July 29, 2022, 240 days after receiving the submission on December 1, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K213760 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170