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13 devices found
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Manufacturer: BunkerHill Health
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
iCAC Device 1.0.0
BunkerHill Health
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
CAC (Gated) Algorithm 1
BunkerHill Health
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Bunkerhill Contrast AVC 1.0.0
BunkerHill Health
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Bunkerhill ECG-EF 1.0.0
BunkerHill Health
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Bunkerhill BMD 1.0.0
BunkerHill Health
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Bunkerhill MAC
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K250662
Active
Cleared 3 Oct 2025
Active
510(k)
510(k)
II
Bunkerhill Contrast CAC
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K260166
Active
Cleared 6 Mar 2026
Active
510(k)
510(k)
II
Bunkerhill Abdominal Aortic Quantification (AAQ)
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K243779
Active
Cleared 1 Jul 2025
Active
510(k)
510(k)
II
Bunkerhill Contrast AVC
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K260167
Active
Cleared 6 Mar 2026
Active
510(k)
510(k)
II
CAC (gated) Algorithm
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K240369
Active
Cleared 27 Sep 2024
Active
510(k)
510(k)
II
Bunkerhill ECG-EF
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K250649
Active
Cleared 19 Sep 2025
Active
510(k)
510(k)
II
BunkerHill BMD
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K242295
Active
Cleared 8 Apr 2025
Active
510(k)
510(k)
II
Bunkerhill AVC
BunkerHill Health
·
,
FDA registration: United States
Class II
FDA 510(k)
K243229
Active
Cleared 27 Jan 2025
Active
510(k)
510(k)
II
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