510(k) Report

FDA applicant

Invivo Corporation (Business Trade Name: Philips)

Florida, FL6 decisions2021–20230 recalls

FDA records 6 decisions for Invivo Corporation (Business Trade Name: Philips) (Florida, FL) from 2021 to 2023: 6 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 79 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Invivo Corporation (Business Trade Name: Philips)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12022: 42023: 1
2021high 4 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Invivo Corporation (Business Trade Name: Philips) by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MOSCoil, Magnetic Resonance, Specialty6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 28 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 79 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213735dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) · 20222cite it
  • K2223258ch Wrist CoilInvivo Corporation (Business Trade Name: Philips) · 20221cites it
  • K213727dS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips) · 20221cites it
  • K232762dS Breast Coil 7ch 1.5TInvivo Corporation (Business Trade Name: Philips) · 20231cites it

What has FDA decided for it lately?

  • K232762dS Breast Coil 7ch 1.5TInvivo Corporation (Business Trade Name: Philips) · 2023
  • K2223258ch Wrist CoilInvivo Corporation (Business Trade Name: Philips) · 2022
  • K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilInvivo Corporation (Business Trade Name: Philips) · 2022
  • K213735dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) · 2022
  • K213727dS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips) · 2022
  • K213351ds Head 32ch 3.0TInvivo Corporation (Business Trade Name: Philips) · 2021

All 6 as Invivo Corporation (Business Trade Name: Philips) →

Other applicant names beginning “Invivo”

FDA records each applicant name separately; these may or may not be the same firm.

Invivo Corporation 39Invivo Research, Inc. 14Invivo Research Labs, Inc. 5Invivo Therapeutics Corporation 1