Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neusoft Medical Systems Co., Ltd. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
227 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230220 | NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2023-10-11 | 258 | 0 |
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2017-12-07 | 227 | 0 |
| K171201 | NeuViz Prime Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2017-09-13 | 142 | 0 |
| K151383 | NeuViz 128 Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2015-11-04 | 166 | 0 |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography ( | Neusoft Medical Systems Co., Ltd. | 2015-11-02 | 160 | 0 |
| K133373 | CLEARVIEW | Neusoft Medical Systems Co., Ltd. | 2014-12-03 | 397 | 0 |
| K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | 2012-11-16 | 141 | 1 |
| K110077 | NEUCOLONCARE | Neusoft Medical Systems Co., Ltd. | 2011-01-28 | 17 | 0 |
| K102435 | BEYONDIMAGE WORKSTATION | Neusoft Medical Systems Co., Ltd. | 2010-10-15 | 50 | 0 |
| K092742 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | 2009-09-22 | 14 | 5 |
| K092237 | NSM-S15 SYSTEM | Neusoft Medical Systems Co., Ltd. | 2009-09-09 | 48 | 0 |
| K092235 | BEYONDIMAGE WORKSTATION | Neusoft Medical Systems Co., Ltd. | 2009-08-06 | 14 | 0 |
| K090552 | UROCARE | Neusoft Medical Systems Co., Ltd. | 2009-03-16 | 14 | 0 |
| K090173 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | 2009-02-05 | 13 | 5 |
| K083877 | FLYING DIAGNOSTIC ULTRASOUND SYSTEM | Neusoft Medical Systems Co., Ltd. | 2009-01-13 | 15 | 0 |
| K082485 | MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A | Neusoft Medical Systems Co., Ltd. | 2008-09-09 | 12 | 0 |
| K080540 | NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 | Neusoft Medical Systems Co., Ltd. | 2008-03-13 | 15 | 0 |
| K072841 | NEUVIZ SPIRAL CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | 2007-10-16 | 12 | 0 |
| K071308 | MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | 2007-08-16 | 99 | 7 |
| K071154 | SUPERSTAR 0.35T MRI SYSTEM | Neusoft Medical Systems Co., Ltd. | 2007-05-10 | 15 | 0 |
| K062860 | MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A | Neusoft Medical Systems Co., Ltd. | 2006-10-27 | 32 | 0 |
| K062451 | NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM | Neusoft Medical Systems Co., Ltd. | 2006-09-28 | 37 | 6 |
| K061132 | MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 | Neusoft Medical Systems Co., Ltd. | 2006-05-24 | 30 | 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