Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
Summary
GE Healthcare received 510(k) clearance for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert, a IYN device. Cleared on 2022-01-13.
Details
Source
510(k) Clearance
External ID
K213642
Action Date
2022-01-13
Status
Traditional
Category
device
Product Code
IYN
Product Description
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert. Product code: IYN.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. GE Healthcare has received 9 total clearances in our database.
GE Healthcare has 32 FDA actions in our database, including 18 recalls and 9 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does GE Healthcare have FDA actions?
GE Healthcare has 32 FDA actions in our database, including 18 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213642" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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