Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OUO — Predicate Candidate Screening
15 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
218 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253963 | Cubresa BrainPET | Cubresa, Inc. | 2026-07-17 | 218 | 0 |
| K253023 | BIOGRAPH One | Siemens Healthineers AG | 2026-01-15 | 118 | 0 |
| K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 | 147 | 0 |
| K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 | 84 | 0 |
| K213709 | SIGNA PET/MR | Ge Medical Systems, LLC | 2022-01-20 | 57 | 3 |
| K200213 | Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. | 2020-05-11 | 104 | 1 |
| K192672 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-11-20 | 55 | 0 |
| K183014 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-27 | 119 | 0 |
| K172531 | Biograph mMR with mMR Angio Transfer Option | Siemens Medical Solutions USA, Inc. | 2017-11-14 | 84 | 0 |
| K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | 2017-02-28 | 103 | 0 |
| K163619 | SIGNA PET/MR | Ge Medical Systems, LLC | 2017-02-14 | 54 | 5 |
| K142098 | SIGNA PET/MR | Ge Medical Systems, LLC | 2014-11-24 | 115 | 5 |
| K133226 | BIOGRAPH MMR | Siemens Medical Solutions USA, Inc. | 2013-11-12 | 22 | 1 |
| K103483 | INGENUITY TF PET/MR | Philips Healthcare (Cleveland) | 2011-11-23 | 362 | 4 |
| K103429 | BIOGRAPH MMR | Siemens Medical Solutions USA, Inc. | 2011-06-08 | 198 | 1 |
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