Submission Details
| 510(k) Number | K241662 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2024 |
| Decision Date | August 30, 2024 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Ultrasound Transducer Cover
Aug 2024
Decision
81d
Days
Class 2
Risk
About This 510(k) Submission
K241662 is an FDA 510(k) clearance for the Ultrasound Transducer Cover, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Vitrolife Sweden AB (V?stra Fr?lunda, SE). The FDA issued a Cleared decision on August 30, 2024, 81 days after receiving the submission on June 10, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.
Device Classification
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1570 |
Manufacturer
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