Bunkerhill AVC
FDA 510(k) K243229 · BunkerHill Health
510(k) numberK243229
Submission
- Device name
- Bunkerhill AVC
- Applicant
- BunkerHill Health
San Francisco, CA, US - Received
- October 8, 2024
- Decision date
- January 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260167 | Bunkerhill Contrast AVCJAK · Traditional | 03/06/2026SE |
| K260166 | Bunkerhill Contrast CACJAK · Traditional | 03/06/2026SE |
| K250662 | Bunkerhill MACJAK · Traditional | 10/03/2025SE |
| K250649 | Bunkerhill ECG-EFQYE · Traditional | 09/19/2025SE |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ)QIH · Traditional | 07/01/2025SE |
| K242295 | BunkerHill BMDKGI · Traditional | 04/08/2025SE |
| K240369 | CAC (gated) AlgorithmJAK · Traditional | 09/27/2024SE |
Questions and answers
When was Bunkerhill AVC cleared by the FDA?
Bunkerhill AVC (K243229) received a 510(k) decision of Substantially Equivalent on January 27, 2025, 111 days after the submission was received.
What is the product code of K243229?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.