Invivo Corporation (Business Trade Name: Philips): FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Invivo Corporation (Business Trade Name: Philips)” (first 2021, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 days. Since 2017 the median was 28 days, against 58 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.
Caduvo groups this applicant name under Philips, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 21 |
| 2022 | 4 | 140 |
| 2023 | 1 | 25 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Invivo Corporation (Business Trade Name: Philips) took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 6 | 6 |
Review panels
- Radiology (6)
Most recent Invivo Corporation (Business Trade Name: Philips) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232762 | dS Breast Coil 7ch 1.5T | MOS | 2023-10-03 | 25 |
| K222325 | 8ch Wrist Coil | MOS | 2022-08-31 | 29 |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | MOS | 2022-08-23 | 27 |
| K213735 | dS Sentinelle Breast 16ch 1.5T Coil | MOS | 2022-08-08 | 252 |
| K213727 | dS Sentinelle Breast 16ch 3.0T Coil | MOS | 2022-08-08 | 255 |
| K213351 | ds Head 32ch 3.0T | MOS | 2021-10-29 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Invivo Corporation (Business Trade Name: Philips).
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 Invivo Corporation (Business Trade Name: Philips) (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
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.
- Invivo Corporation (39 510(k)s)
- Invivo Research, Inc. (14 510(k)s)
- Invivo Research Labs, Inc. (5 510(k)s)
- Invivo Therapeutics Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Invivo Corporation (Business Trade Name: Philips)?
FDA lists 6 510(k) clearances under the applicant name “Invivo Corporation (Business Trade Name: Philips)” (first 2021, latest 2023), 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 Invivo Corporation (Business Trade Name: Philips)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invivo Corporation (Business Trade Name: Philips) is 28 days. Since 2017: 28 days, versus 58 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Invivo Corporation (Business Trade Name: Philips)?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 6).
Next steps
- See all 6 Invivo Corporation (Business Trade Name: Philips) clearances with predicates and recalls
- Run predicate analysis for product code MOS, Invivo Corporation (Business Trade Name: Philips)'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.