Invivo Corporation: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Invivo Corporation” (first 2005, latest 2021), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 41 days. Since 2017 the median was 26 days, against 142 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 |
|---|---|---|
| 2012 | 4 | 47 |
| 2013 | 3 | 53 |
| 2014 | 1 | 118 |
| 2015 | 2 | 76 |
| 2016 | 2 | 42 |
| 2017 | 0 | — |
| 2018 | 1 | 31 |
| 2019 | 2 | 39 |
| 2020 | 0 | — |
| 2021 | 3 | 22 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Invivo Corporation took a median 26 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 21 | 21 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 8 | 8 |
| LLZ | System, Image Processing, Radiological | 7 | 7 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
Review panels
- Radiology (28)
- Cardiovascular (10)
- Anesthesiology (1)
Most recent Invivo Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T | MOS | 2021-12-23 | 22 |
| K212227 | Philips MR Patient Care Portal | MWI | 2021-09-30 | 76 |
| K212175 | DynaCAD | LLZ | 2021-08-02 | 21 |
| K193403 | UroNav System | LLZ | 2019-12-27 | 21 |
| K192200 | DynaCAD | LLZ | 2019-10-09 | 57 |
| K182561 | UroNav (Version 3.0) | LLZ | 2018-10-19 | 31 |
| K162177 | dS FootAnkle I6CH 1.5T Coil | MOS | 2016-09-14 | 41 |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | MOS | 2016-08-31 | 42 |
| K152330 | Expression MR400 MRI Patient Monitoring System | MWI | 2015-12-23 | 127 |
| K153073 | UroNav (Version 2.0) | LLZ | 2015-11-16 | 25 |
29 earlier clearances. See the full list in Caduvo.
Recalls
22 product recalls in 22 recall events; 0 initiated in the last five years. Most recent: 2020-09-14.
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 (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 Research, Inc. (14 510(k)s)
- Invivo Corporation (Business Trade Name: Philips) (6 510(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?
FDA lists 39 510(k) clearances under the applicant name “Invivo Corporation” (first 2005, latest 2021), across 5 product codes in 3 review panels. 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invivo Corporation is 41 days. Since 2017: 26 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Invivo Corporation?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 21); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 8); LLZ (System, Image Processing, Radiological, 7).
Next steps
- See all 39 Invivo Corporation clearances with predicates and recalls
- Run predicate analysis for product code MOS, Invivo Corporation'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.