Ablate-Iq
FDA 510(k) K232227 · Neuwave Medical, Inc.
510(k) numberK232227
Submission
- Device name
- Ablate-Iq
- Applicant
- Neuwave Medical, Inc.
Madision, WI, US - Received
- July 27, 2023
- Decision date
- April 4, 2024
- 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 |
|---|---|---|
| K231738 | NEUWAVE Microwave Ablation System and AccessoriesNEY · Traditional | 11/16/2023SE |
| K220472 | NEUWAVE Microwave Ablation System and AccessoriesNEY · Traditional | 08/11/2022SE |
| K200081 | NEUWAVE Microwave Ablation System and AccessoriesNEY · Traditional | 11/13/2020SE |
| K192427 | Ablation ConfirmationJAK · Special | 10/03/2019SE |
| K173756 | Certus 140 2.45GHz Ablation SystemNEY · Traditional | 10/24/2018SE |
| K171022 | Ablation ConfirmationJAK · Special | 05/09/2017SE |
| K163118 | FLEX Microwave Ablation System and AccessoriesNEY · Traditional | 03/09/2017SE |
| K161285 | Ablation ConfirmationJAK · Special | 06/29/2016SE |
| K160936 | Certus 140 2.45GHz Ablation SystemNEY · Special | 05/04/2016SE |
| K150313 | Ablation ConfirmationLLZ · Traditional | 07/09/2015SE |
Questions and answers
When was Ablate-Iq cleared by the FDA?
Ablate-Iq (K232227) received a 510(k) decision of Substantially Equivalent on April 4, 2024, 252 days after the submission was received.
What is the product code of K232227?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.