ClearanceBrief
Company ยท US

BunkerHill Health

FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JAKSystem, X-Ray, Tomography, Computed5
KGIDensitometer, Bone1
QIHAutomated Radiological Image Processing Software1
QYEReduced Ejection Fraction Machine Learning-Based Notification Software1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 6, 2026K260167Bunkerhill Contrast AVC
BunkerHill Health
JAK
Mar 6, 2026K260166Bunkerhill Contrast CAC
BunkerHill Health
JAK
Oct 3, 2025K250662Bunkerhill MAC
BunkerHill Health
JAK
Sep 19, 2025K250649Bunkerhill ECG-EF
BunkerHill Health
QYE
Jul 1, 2025K243779Bunkerhill Abdominal Aortic Quantification (AAQ)
BunkerHill Health
QIH
Apr 8, 2025K242295BunkerHill BMD
BunkerHill Health
KGI
Jan 27, 2025K243229Bunkerhill AVC
BunkerHill Health
JAK
Sep 27, 2024K240369CAC (gated) Algorithm
BunkerHill Health
JAK

Latest recalls

DateFirm and productCodeLinked 510(k)
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