Neusoft Medical Systems Co., Ltd.
Neusoft Medical Systems Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2023, with 8 FDA device recalls on record.
Top product codes for Neusoft Medical Systems Co., Ltd.
FDA recalls by Neusoft Medical Systems Co., Ltd.
- Z-1281-2019 — NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Z-1280-2019 — NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Z-1279-2019 — NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Z-3045-2017 — Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Z-3044-2017 — Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Z-0876-2017 — NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
- Z-0875-2017 — NeuViz 64 Multi-slice CT Scanner Systems
- Z-1650-2016 — NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Neusoft Medical Systems Co., Ltd.
- K230220 — NeuViz 128 Multi-Slice CT Scanner System
- K171198 — NeuViz 16 Essence Multi-slice CT Scanner System
- K171201 — NeuViz Prime Multi-slice CT Scanner System
- K151383 — NeuViz 128 Multi-slice CT Scanner System
- K151403 — Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
- K133373 — CLEARVIEW
- K121792 — NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
- K110077 — NEUCOLONCARE
- K102435 — BEYONDIMAGE WORKSTATION
- K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- K092237 — NSM-S15 SYSTEM
- K092235 — BEYONDIMAGE WORKSTATION
- K090552 — UROCARE
- K090173 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- K083877 — FLYING DIAGNOSTIC ULTRASOUND SYSTEM
- K082485 — MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
- K080540 — NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
- K072841 — NEUVIZ SPIRAL CT SCANNER SYSTEM
- K071308 — MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
- K071154 — SUPERSTAR 0.35T MRI SYSTEM
- K062860 — MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
- K062451 — NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
- K061132 — MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
Data sourced from openFDA. This site is unofficial and independent of the FDA.