510(k) K222222
- Device
- Artemis, Artemis TPO, Artemis MX
- Applicant
- Eigen
- 510(k) number
- K222222
- Product code
- QTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-12
- Date received
- 2022-07-25
- 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
- No
Applicant Contact#
- Contact
- William Mandel
- Address
- 13366 Grass Valley Ave. Grass Valley CA US 95945 95945
FDA Registration Numbers#
- 2937707
- 3007137598
- 3023385454
- 3004363352
- 3015232217
- 3006894636
- 3030089065
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 |
| 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 |