Medis Medical Imaging Systems BV: FDA filings under this applicant name

FDA lists 17 510(k) clearances under the applicant name “Medis Medical Imaging Systems BV” (first 1999, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 73 days. 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 Medis Medical Imaging Systems BV took a median 251 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.

Top product codes

Review panels

• Radiology (17)

Most recent Medis Medical Imaging Systems BV 510(k) clearances

7 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Medis Medical Imaging Systems BV.

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 Medis Medical Imaging Systems BV (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.

• Medis Medical Imaging Systems, Inc. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Medis Medical Imaging Systems BV?

FDA lists 17 510(k) clearances under the applicant name “Medis Medical Imaging Systems BV” (first 1999, latest 2019), 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 Medis Medical Imaging Systems BV?

The median time from FDA receipt to decision across 510(k)s cleared under the name Medis Medical Imaging Systems BV is 73 days.

Which FDA product codes appear under Medis Medical Imaging Systems BV?

The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 8); IZI (System, X-Ray, Angiographic, 3); LNH (System, Nuclear Magnetic Resonance Imaging, 3).

Next steps

• See all 17 Medis Medical Imaging Systems BV clearances with predicates and recalls
• Run predicate analysis for product code LLZ, Medis Medical Imaging Systems BV'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.

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