Siemens Medical Solution: FDA filings under this applicant name

FDA lists 4 510(k) clearances under the applicant name “Siemens Medical Solution” (first 2005, latest 2012), plus 1 PMA decision, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.

510(k) clearances per year

Top product codes

Review panels

• Radiology (5)

Most recent Siemens Medical Solution 510(k) clearances

PMA and De Novo decisions

Recalls

openFDA lists no recalls under a recalling firm named Siemens Medical Solution.

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 Siemens Medical Solution (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.

• Siemens Medical Solutions USA, Inc. (784 510(k)s)
• Siemens Healthcare Diagnostics, Inc. (245 510(k)s)
• Siemens Corp. (67 510(k)s)
• Siemens Elema AB (63 510(k)s)
• Siemens Gammasonics, Inc. (53 510(k)s)
• Siemens Hearing Instruments, Inc. (42 510(k)s)
• Siemens Healthcare GmbH (32 510(k)s)
• Siemens Medi Cal Solutions, Inc. (32 510(k)s)
• Siemens AG Medical Solutions (31 510(k)s)
• Siemens Medical Systems, Inc. (25 510(k)s)
• Siemens Healthcare Diagnostics Products GmbH (23 510(k)s)
• Siemens AG (15 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Siemens Medical Solution?

FDA lists 4 510(k) clearances under the applicant name “Siemens Medical Solution” (first 2005, latest 2012), plus 1 PMA decision, 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 Siemens Medical Solution?

The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Medical Solution is 48 days.

Which FDA product codes appear under Siemens Medical Solution?

The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1); JAK (System, X-Ray, Tomography, Computed, 1); KPR (System, X-Ray, Stationary, 1).

Next steps

• See all 4 Siemens Medical Solution clearances with predicates and recalls
• Run predicate analysis for product code IYN, Siemens Medical Solution'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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