Neusoft Medical Systems Co., Ltd.: FDA filings under this applicant name

FDA lists 23 510(k) clearances under the applicant name “Neusoft Medical Systems Co., Ltd.” (first 2006, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 32 days. Since 2017 the median was 227 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Neusoft Medical Systems Co., Ltd. took a median 227 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.

Top product codes

Review panels

• Radiology (23)

Most recent Neusoft Medical Systems Co., Ltd. 510(k) clearances

13 earlier clearances. See the full list in Caduvo.

Recalls

8 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-10-22.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Neusoft Medical Systems Co., Ltd. (a text match, not an official crosswalk):

• C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
• C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
• C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
• C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
• C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Neusoft Digital Medical Systems Co., Ltd. (4 510(k)s)
• Neusoft Positron Medical Systems Co., Ltd. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Neusoft Medical Systems Co., Ltd.?

FDA lists 23 510(k) clearances under the applicant name “Neusoft Medical Systems Co., Ltd.” (first 2006, latest 2023), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Neusoft Medical Systems Co., Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Neusoft Medical Systems Co., Ltd. is 32 days. Since 2017: 227 days, versus 118 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Neusoft Medical Systems Co., Ltd.?

The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 12); LNH (System, Nuclear Magnetic Resonance Imaging, 5); LLZ (System, Image Processing, Radiological, 4).

Next steps

• See all 23 Neusoft Medical Systems Co., Ltd. clearances with predicates and recalls
• Run predicate analysis for product code JAK, Neusoft Medical Systems Co., Ltd.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

All FDA device companies · FDA product code lookup