MIMOSA Imager

K190334

MIMOSA Diagnostics Inc · cleared 2019-11-01 · product code MUD · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The MIMOSA Imager is a non-contacting, cordless, battery powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device captures spatially-resolved images that is triggered by the end user via a smartphone-app interface. By tracking the spectral signatures of dominant chromophores in the patient's superficial tissue, the device calculates and displays the StO2 estimate on the connected android device screen.”
AlgorithmThe device calculates and displays the StO2 estimate on the connected android device screen by tracking the spectral signatures of dominant chromophores in the patient's superficial tissue. Spectral analysis is used to measure StO2 using specific both visible (VIS) and near-infrared (NIR) LED-illuminated wavelengths.
source quote (p.5)
“The MIMOSA Imager is a non-contacting, cordless, battery powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device captures spatially-resolved images that is triggered by the end user via a smartphone-app interface. By tracking the spectral signatures of dominant chromophores in the patient's superficial tissue, the device calculates and displays the StO2 estimate on the connected android device screen. The MIMOSA Imager shares fundamental principles with other oximeters and tissue oxygenation measurement systems. Tissue oximetry exposes tissue to optical radiation of known wavelengths and captures the remitted or reflected light. The remitted back scattered light is then used to calculate StO2 based on principles of multispectral imaging. Spectral analysis is used to measure StO2 using specific both visible (VIS) and near-infrared (NIR) LED-illuminated wavelengths.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: Spectral response to varying amperage; Transmittance profile, as a function of wavelength; Stress testing device for endurance, consistency and maximum output

standards: IEC 62471

Standalone

n=39 patients

endpoints: demonstrate substantial equivalence between the two devices; 95% confidence interval of the line of best fit narrowly constrains the slope of the line between 0.998 and 1.02

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
38
MAUDE reports in code, 12mo
-67%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K190334