Product code MOS: 510(k) clearances and predicates

Product code MOS covers 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. FDA lists 490 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

490 clearances on file under product code MOS. Counts by year:

Year	Clearances
2022	11
2023	10
2024	10
2025	3
2026 so far	9

Recent clearances

Newest MOS clearances in the FDA index, with applicant and decision date:

• K262330, 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, applicant Philips Medical Systems Nederland B.V., decided 2026-07-30. FDA record
• K262294, dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T, applicant Philips Medical Systems Nederland B.V., decided 2026-07-24. FDA record
• K260947, 0.55T 12Ch Breast Coil, applicant Neocoil, LLC, decided 2026-04-23. FDA record
• K252587, HD 8Ch Wrist Array, applicant Shenzhen RF Tech Co., Ltd., decided 2026-04-14. FDA record
• K252876, GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only, applicant Shenzhen RF Tech Co., Ltd., decided 2026-04-01. FDA record
• K260519, Smart Fit TorsoCardiac 1.5T, applicant Philips Healthcare (Suzhou) Co., Ltd., decided 2026-03-20. FDA record
• K252179, GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only, applicant Shenzhen RF Tech Co., Ltd., decided 2026-02-10. FDA record
• K253738, 3.0T AIR 32CH HNA, applicant Ge Healthcare Coils (Usa Instruments, Inc.), decided 2026-01-23. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T, 0.55T 12Ch Breast Coil. Watch new MOS clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code MOS?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MOS clearances include 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.

How many 510(k) clearances use product code MOS?

490 at the time this page was generated, from openFDA records.

How do I find a predicate device under MOS?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new MOS clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.