Atlas FDA

3.0T AIR 32CH HNA

FDA 510(k) clearance K253738 · decided 2026-01-23

Clearance details

K-number
K253738
Device name
3.0T AIR 32CH HNA
Applicant
Ge Healthcare Coils (Usa Instruments, Inc.)
Decision
Substantially Equivalent
Date received
2025-11-24
Decision date
2026-01-23
Days to decision
60 days
Clearance type
Abbreviated
Product code
MOS
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Aurora, OH, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ge Healthcare Coils (Usa Instruments

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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 (K262330)Philips Medical Systems Nederland B.V.2026-07-30
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 (K262294)Philips Medical Systems Nederland B.V.2026-07-24
0.55T 12Ch Breast Coil (K260947)Neocoil, LLC2026-04-23
HD 8Ch Wrist Array (K252587)Shenzhen RF Tech Co., Ltd.2026-04-14
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 (K252876)Shenzhen RF Tech Co., Ltd.2026-04-01
Smart Fit TorsoCardiac 1.5T (K260519)Philips Healthcare (Suzhou) Co., Ltd.2026-03-20
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 (K252179)Shenzhen RF Tech Co., Ltd.2026-02-10
dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (K254190)Philips Medical Systems Nederland B.V.2026-01-14
InkSpace Imaging Small Body Array (SBA12PH30x) (K253182)Inkspace Imaging, Inc.2025-10-20
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector (K243428)Dxtx Medical, Inc.2025-07-17
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) (K244054)Quality Electrodynamics2025-02-28
InkSpace Imaging Small Body Array (K243675)Inkspace Imaging, Inc.2024-12-20

Recalls involving this device

No recalls on record reference this clearance.