Bruker Medical Imaging, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bruker Medical Imaging, Inc.” (first 1989, latest 1992), across 1 product code in 1 review panel. Median 510(k) review time under this name: 114 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 7 | 7 |
Review panels
- Radiology (7)
Most recent Bruker Medical Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915657 | MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28 | LNH | 1992-03-13 | 86 |
| K913463 | MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN | LNH | 1991-11-29 | 116 |
| K903661 | BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD | LNH | 1990-11-13 | 92 |
| K900026 | BRUKER R28 WHOLE-BODY MR SCANNER | LNH | 1990-04-30 | 117 |
| K895328 | MAGNETIC RESONANCE SYSTEM MODEL BMT-1100 | LNH | 1990-03-09 | 190 |
| K894714 | 1989 SOFTWARE REVISION TO THE BMT-1100 | LNH | 1989-11-15 | 114 |
| K891760 | MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED | LNH | 1989-06-23 | 92 |
Recalls
openFDA lists no recalls under a recalling firm named Bruker Medical Imaging, Inc..
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 Bruker Medical Imaging, Inc. (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.
- Bruker Daltonik GmbH (2 510(k)s)
- Bruker Daltonics, Inc. (2 510(k)s)
- Bruker Daltonics GmbH & Co. KG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bruker Medical Imaging, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Bruker Medical Imaging, Inc.” (first 1989, latest 1992), across 1 product code 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 Bruker Medical Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bruker Medical Imaging, Inc. is 114 days.
Which FDA product codes appear under Bruker Medical Imaging, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 7).
Next steps
- See all 7 Bruker Medical Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Bruker Medical Imaging, Inc.'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.