510(k) K252947
- Device
- HistoSonics® Planning Tool
- Applicant
- HistoSonics, Inc.
- 510(k) number
- K252947
- Product code
- QTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-29
- Date received
- 2025-09-15
- Regulation
- 892.2050
- Classification name
- Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- LeeAnne Swiridow
- Address
- 16305 36th Ave. N. Suite 300 Plymouth MN US 55446 55446
FDA Registration Numbers#
- 3006894636
- 3015232217
- 3030089065
- 3023385454
- 2937707
- 3007137598
- 3004363352
Source Documents#
Other 510(k) Records For Product Code QTZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies | 2025-09-08 |
| K240796 | myAblation Guide (VB80A) | Siemens Healthcare GmbH | 2024-08-06 |
| K240773 | VisAble.IO | Techsomed | 2024-04-15 |
| K222222 | Artemis, Artemis TPO, Artemis MX | Eigen | 2023-10-12 |
| K222938 | Ablation-fit | R.A.W. S.R.L | 2023-09-12 |
| K223639 | VisAble.IO | Techsomed | 2023-08-28 |
| K220256 | MIM-Ablation | Mim Software, Inc. | 2022-10-07 |