dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16
Summary
Philips Medical Systems Nederland B.V. received 510(k) clearance for dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T, a MOS device. Cleared on 2026-07-30.
Details
Source
510(k) Clearance
External ID
K262330
Action Date
2026-07-30
Status
Special
Category
device
Product Code
MOS
Product Description
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T. Product code: MOS.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 341 device clearances issued this month. Philips Medical Systems Nederland B.V. has received 34 total clearances in our database.
Philips Medical Systems Nederland B.V. has 237 FDA actions in our database, including 203 recalls and 34 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 Philips Medical Systems Nederland B.V. have FDA actions?
Philips Medical Systems Nederland B.V. has 237 FDA actions in our database, including 203 recalls and 34 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K262330" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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