Cardiovascular · 510(k) · 2019
MIMOSA Imager
MIMOSA Diagnostics Inc. Cleared by FDA on 1 November 2019 under submission K190334, product code MUD (oximeter, tissue saturation). What FDA's record says, in FDA's words.
Device record · K190334
- Device. MIMOSA ImagerDEVICE
- Company. MIMOSA Diagnostics Inc (CA)COMPANY
- Decision. 1 November 2019, 510(k), substantially equivalent (traditional review); received 14 February 2019DECISION
- Panel. CardiovascularPANEL
- Product code. MUD, Oximeter, Tissue SaturationCODE
- Regulation. 21 CFR 870.2700, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The MIMOSA Imager is intended to non-invasively estimate the spatial distribution of percent oxygen saturation (StO2) in a volume of ti ssue. This is performed in medical environments inclu ding physician offices, hospitals, ambulatory care and Emergency Medical Services. The MIMOSA I mager is indicated for use in monitorin g patients during circu latory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulatio n.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 744 reports filed against devices carrying product code MUD. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
28 September 2026 · Malfunction · HEMOSPHERE FORESIGHT MODULE · Edwards Lifesciences · report 2015691-2026-18905
28 September 2026 · Malfunction · INVOS · Covidien llc · report 2936999-2026-00409
28 September 2026 · Malfunction · O3 Regional Oximeter · Masimo - 15750 Alton Pkwy · report 3019388613-2026-00701
22 September 2026 · Malfunction · INVOS · Covidien llc · report 2936999-2026-00398
It was reported that the device was not reading correctly. There was no patient involvement.
3 September 2026 · Malfunction · HEMOSPHERE FORESIGHT MODULE · Edwards Lifesciences · report 2015691-2026-18272
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MUD, in Cardiovascular, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.