Instrumentarium Imaging, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Instrumentarium Imaging, Inc.” (first 1989, latest 2000), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 14 | 14 |
| IZH | System, X-Ray, Mammographic | 6 | 6 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Review panels
- Radiology (24)
Most recent Instrumentarium Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002472 | DELTA 32 AND DELTA 32 TACT | IZH | 2000-11-29 | 110 |
| K001928 | SIGMA | MUH | 2000-08-02 | 37 |
| K000976 | DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) | IZH | 2000-06-01 | 66 |
| K001171 | DELTA 16 TACT | IZH | 2000-05-12 | 31 |
| K973642 | ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 | EHD | 1997-11-21 | 58 |
| K955411 | DELTA 16 | IZH | 1996-03-21 | 115 |
| K925987 | INSTRUMENTARIUM MEGA4 HT | LNH | 1993-05-19 | 175 |
| K924921 | INSTRUMENTARIUM MEGA4 HT | LNH | 1993-05-17 | 234 |
| K924472 | INSTRUMENTARIUM MEGA4 HT | LNH | 1993-05-03 | 243 |
| K923581 | INSTRUMENTARIUM MEGA4 HT | LNH | 1993-05-03 | 287 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Instrumentarium 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 Instrumentarium 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.
- Instrumentarium Corp. (20 510(k)s)
- Instrumentarium Dental, Palodex Group OY (5 510(k)s)
- Instrumentarium Corp. Imaging Division (3 510(k)s)
- Instrumentarium-Datex (2 510(k)s)
- Instrumentarium Dental, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instrumentarium Imaging, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Instrumentarium Imaging, Inc.” (first 1989, latest 2000), across 6 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 Instrumentarium Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instrumentarium Imaging, Inc. is 90 days.
Which FDA product codes appear under Instrumentarium Imaging, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 14); IZH (System, X-Ray, Mammographic, 6); EHD (Unit, X-Ray, Extraoral With Timer, 1).
Next steps
- See all 24 Instrumentarium Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Instrumentarium 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.