Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MOS — Predicate Candidate Screening
490 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
119 days90th percentile
490clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Br | Philips Medical Systems Nederland B.V. | 2026-07-30 | 21 | 0 |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/ | Philips Medical Systems Nederland B.V. | 2026-07-24 | 17 | 0 |
| K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | 2026-04-23 | 31 | 0 |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | 2026-04-14 | 242 | 0 |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 1 | Shenzhen RF Tech Co., Ltd. | 2026-04-01 | 203 | 0 |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-20 | 31 | 0 |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 1 | Shenzhen RF Tech Co., Ltd. | 2026-02-10 | 214 | 0 |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026-01-23 | 60 | 0 |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS H | Philips Medical Systems Nederland B.V. | 2026-01-14 | 22 | 0 |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | 2025-10-20 | 24 | 0 |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Sy | Dxtx Medical, Inc. | 2025-07-17 | 254 | 0 |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER | Quality Electrodynamics | 2025-02-28 | 59 | 0 |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-12-20 | 23 | 0 |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2024-11-19 | 28 | 0 |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 | 21 | 0 |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 | 25 | 0 |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-08-12 | 25 | 0 |
| K241069 | iLoop Interventional Coil 0.55T | Noras Mri Products GmbH | 2024-06-07 | 49 | 0 |
| K233652 | Contour Hand/Wrist (Q7000232) | Quality Electrodynamics | 2024-02-16 | 94 | 0 |
| K233656 | Contour Shoulder | Quality Electrodynamics | 2024-02-15 | 93 | 0 |
| K233600 | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | 2024-02-05 | 88 | 0 |
| K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-01-08 | 81 | 0 |
| K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | 2023-10-24 | 25 | 0 |
| K232762 | dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) | 2023-10-03 | 25 | 0 |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2023-09-01 | 56 | 0 |
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. | 2023-08-18 | 123 | 0 |
| K223484 | IGAR System (1001.A) | Insight Medbotics, Inc. | 2023-07-20 | 244 | 0 |
| K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2023-06-29 | 24 | 0 |
| K223225 | 8ch T/R Knee Coil | Shenzhen RF Tech Co., Ltd. | 2023-02-14 | 119 | 0 |
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | Rapid Biomedical GmbH | 2023-02-01 | 460 | 0 |
| K223429 | Contour Knee | Quality Electrodynamics, LLC | 2023-01-13 | 60 | 0 |
| K223378 | 3.0T 16ch AIR AA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2023-01-03 | 57 | 0 |
| K212239 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2022-12-23 | 522 | 0 |
| K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc. | 2022-12-08 | 17 | 0 |
| K223239 | 8ch Wrist Coil | Shenzhen RF Tech Co., Ltd. | 2022-12-08 | 49 | 0 |
| K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, | Neocoil, LLC | 2022-10-14 | 66 | 0 |
| K222325 | 8ch Wrist Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-31 | 29 | 0 |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-23 | 27 | 0 |
| K213727 | dS Sentinelle Breast 16ch 3.0T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 | 255 | 0 |
| K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 | 252 | 0 |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Brea | Noras Mri Products GmbH | 2022-04-08 | 79 | 0 |
| K213687 | 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior | Neocoil, LLC | 2022-03-11 | 108 | 0 |
| K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head H | Noras Mri Products GmbH | 2022-03-03 | 279 | 0 |
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWris | Invivo Corporation | 2021-12-23 | 22 | 0 |
| K213397 | InkSpace Imaging Pediatric Body Array | Inkspace Imaging, Inc. | 2021-12-17 | 60 | 0 |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2021-12-01 | 84 | 0 |
| K213351 | ds Head 32ch 3.0T | Invivo Corporation (Business Trade Name: Philips) | 2021-10-29 | 21 | 0 |
| K200836 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | 2020-07-22 | 113 | 0 |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | Neocoil, LLC | 2020-06-02 | 39 | 0 |
| K200477 | Flex Body Speeder | Quality Electrodynamics, LLC | 2020-04-08 | 41 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda