CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
FDA 510(k) K231870 · Ge Medical Systems Information Technologies, Inc.
510(k) numberK231870
Submission
- Device name
- CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
- Applicant
- Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US - Received
- June 26, 2023
- Decision date
- December 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…DQK · Special | 12/12/2024SE |
| K233810 | Portrait VSMMWI · Traditional | 04/25/2024SE |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application…MWI · Traditional | 03/20/2024SE |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services…MWI · Traditional | 08/11/2023SE |
| K230145 | One-CufDXQ · Traditional | 03/14/2023SE |
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Questions and answers
When was CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System cleared by the FDA?
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (K231870) received a 510(k) decision of Substantially Equivalent on December 13, 2023, 170 days after the submission was received.
What is the product code of K231870?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.