510(k) Report

FDA applicant

Invivo Corporation

Florida, FL39 decisions2005–202125 recalls

FDA records 39 decisions for Invivo Corporation (Florida, FL) from 2005 to 2021: 39 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 36 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 18 of them its own earlier devices. 25 recalls are linked to its devices.

FDA’s records also spell it “Invivo”, “Invivo Corp.”.

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’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2007: 22008: 32009: 22010: 22011: 32012: 42013: 32014: 12015: 22016: 22018: 12019: 22021: 3
2007high 4 (2012) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

5in 2024

2008: 12010: 12011: 12012: 12013: 22014: 52015: 12018: 12020: 62022: 12024: 5
2007high 6 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Invivo Corporation by year, 2007–2026Sources: 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, Specialty21decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)8decisions
  • LLZSystem, Image Processing, Radiological7decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions
  • DQAOximeter1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 36 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 7 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 45 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 47 times; 18 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.

  • K153073UroNav (Version 2.0)Invivo Corporation · 20155cite it
  • K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp. · 20094cite it
  • K192200DynaCADInvivo Corporation · 20193cite it
  • K1116731.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation · 20113cite it
  • K061952Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16Invivo · 20063cite it
  • K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 20063cite it

What has FDA decided for it lately?

  • K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small…Invivo Corporation · 2021
  • K212227Philips MR Patient Care PortalInvivo Corporation · 20211 recall
  • K212175DynaCADInvivo Corporation · 2021
  • K193403UroNav SystemInvivo Corporation · 2019
  • K192200DynaCADInvivo Corporation · 2019
  • K182561UroNav (Version 3.0)Invivo Corporation · 2018
  • K162177dS FootAnkle I6CH 1.5T CoilInvivo Corporation · 2016
  • K1620011.5T and 3.0T 16 CH GE Shoulder CoilsInvivo Corporation · 20161 recall

All 29 as Invivo Corporation →All 6 as Invivo →All 4 as Invivo Corp. →

What has been recalled?

25 recalls linked to its devices; the latest:

  • K072873dS Breast 16ch 1.5TNov 4, 2024Class II
  • K072873dS Breast 16ch 3.0TNov 4, 2024Class II
  • K072873Mammotrak Diagnostic Coil 1.5TNov 4, 2024Class II
  • K093284ST SENSE Breast Dx CoilNov 4, 2024Class II
  • K072873Mammotrak Diagnostic Coil 3.0TNov 4, 2024Class II
  • K212227MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a…Sep 6, 2022Class II

Other applicant names beginning “Invivo”

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

Invivo Research, Inc. 14Invivo Corporation (Business Trade Name: Philips) 6Invivo Research Labs, Inc. 5Invivo Therapeutics Corporation 1