MIM-Ablation
FDA 510(k) clearance K220256 · decided 2022-10-07
Clearance details
- K-number
- K220256
- Device name
- MIM-Ablation
- Applicant
- Mim Software, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-31
- Decision date
- 2022-10-07
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- QTZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Beachwood, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| myAblation Guide (VC10A) (K253264) | Siemens Healthcare GmbH | 2026-06-16 |
| HistoSonicsĀ® Planning Tool (K252947) | HistoSonics, Inc. | 2026-05-29 |
| BioTraceIO Vision (V1.7) (K251931) | Techsomed Medical Technologies | 2025-09-08 |
| myAblation Guide (VB80A) (K240796) | Siemens Healthcare GmbH | 2024-08-06 |
| VisAble.IO (K240773) | Techsomed | 2024-04-15 |
| Artemis, Artemis TPO, Artemis MX (K222222) | Eigen | 2023-10-12 |
| Ablation-fit (K222938) | R.A.W. S.R.L | 2023-09-12 |
| VisAble.IO (K223639) | Techsomed | 2023-08-28 |
Recalls involving this device
No recalls on record reference this clearance.