Submission Details
| 510(k) Number | K231870 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Dec 2023
Decision
170d
Days
Class 2
Risk
About This 510(k) Submission
K231870 is an FDA 510(k) clearance for the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on December 13, 2023, 170 days after receiving the submission on June 26, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.
Device Classification
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1425 |
Manufacturer
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI · US
Manjunatha K N
31 submissions
31 cleared
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