510(k) K220256
- Device
- MIM-Ablation
- Applicant
- MIM Software Inc.
- 510(k) number
- K220256
- Product code
- QTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-07
- Date received
- 2022-01-31
- Regulation
- 510(k) Premarket Notification
- Classification name
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Daniel Darkow
- Address
- 25800 Science Park Dr. - Suite 180 Beachwood OH US 44122 44122
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 |
|---|---|---|---|
| K252947 | HistoSonics® Planning Tool | HistoSonics, Inc. | 2026-05-29 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases