Radiology · 510(k) · 2025
BunkerHill BMD
BunkerHill Health. Cleared by FDA on 8 April 2025 under submission K242295, product code KGI (densitometer, bone). What FDA's record says, in FDA's words.
Device record · K242295
- Device. BunkerHill BMDDEVICE
- Company. BunkerHill HealthCOMPANY
- Decision. 8 April 2025, 510(k), substantially equivalent (traditional review); received 2 August 2024DECISION
- Panel. RadiologyPANEL
- Product code. KGI, Densitometer, BoneCODE
- Regulation. 21 CFR 892.1170, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre- specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement. Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 59 reports filed against devices carrying product code KGI. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · HORIZON-C · Hologic, Inc. · report 3005496266-2026-00267
The Field Service Engineer (FSE) reported while performing a preventative maintenance (PM) on the device, "electrical smoke came from the tank area." The FSE installed a new tank (x-ray tube housing assembly) and indicated the system was ready for normal use. No patient or user harm was reported.
25 September 2026 · Injury · Horizon C · Hologic, Inc. · report 3005496266-2026-00278
22 December 2025 · Injury · PRODIGY · GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. · report 9616047-2025-00002
ON (B)(6) 2025, (B)(6) REPORTED AN INCIDENT INVOLVING A PRODIGY DENSITOMETRY SYSTEM PHANTOM. DURING HANDLING, THE PHANTOM WAS ACCIDENTALLY DROPPED, STRIKING THE OPERATORÂ'S FOOT, CAUSING A FRACTURE IN THE RIGHT FOOT BIG TOE. NO DEVICE MALFUNCTION WAS REPORTED; THE EVENT OCCURRED DURING ROUTINE HANDLING OF THE PHANTOM. ALTHOUGH THE INJURY OCCURRED ON (B)(6) 2025, THE CUSTOMER DID NOT INFORM GE HEALTHCARE UNTIL 10-DEC-2025.
10 November 2025 · Malfunction · HORIZON · HOLOGIC INC · report 3005496266-2025-00093
IT WAS REPORTED BY THE USER SITE THAT PRIOR TO A HORIZON PROCEDURE ON (B)(6) 2025, A TECHNOLOGIST RECEIVED AN ELECTROSTATIC DISCHARGE (ESD) WHEN PRESSING A CONTROL PANEL BUTTON. THE USER SITE ALSO REPORTED THAT THE CONTROL PANEL SHUT DOWN AFTER THE ESD. NO INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM AND COULD NOT REPRODUCE THE ESD. T HE FSE REPLACED THE CONTROL PANEL OF THE DEVICE AND VERIFIED THAT THE SYSTEM IS NOW OPERATING ACCORDING TO […]
23 October 2025 · Malfunction · HORIZON · HOLOGIC INC · report 3005496266-2025-00077
IT WAS REPORTED BY THE USER SITE THAT DURING A HORIZON PROCEDURE ON (B)(6) 2025, THE TECHNOLOGIST RECEIVED AN ELECTROSTATIC DISCHARGE (ESD) WHEN PRESSING A BUTTON ON THE CONTROL PANEL, AND THE SYSTEM SHUT DOWN. A SECOND STAFF MEMBER AT THE USER SITE REPORTS THAT THEY DID NOT EXPERIENCE ANY SHOCKS WHEN TOUCHING THE BUTTONS ON THE CONTROL PANEL. A HOLOGIC TECHNICAL SUPPORT (TS) AGENT CONTACTED THE USER SITE TO INQUIRE ABOUT THE STATUS OF THE REPORTED PROBLEM. THE USER SITE REPORTED TO TS THAT […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code KGI, in Radiology, from BunkerHill Health, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.