MIMOSA Imager: FDA 510(k) K190334, Mimosa Diagnostics, Inc.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK190334	Date1 Nov 2019Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K190334

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K190334
FDA product code: MUD

Device class: Class II
Regulation: 21 CFR Part 870.2700
Advisory committee: Cardiovascular
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 K042657 10 Jan 2005 FDA record

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K190334

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K190334
		UDI-DI	Size and differences
MIMOSA Pro Mimosa Diagnostics, Inc.	MIMOSA Pro	00627987881806	—	On the market

Similar devices

Other devices filed under FDA product code MUD (Oximeter, Tissue Saturation).

Other devices from Mimosa Diagnostics, Inc.

MIMOSA Pro

Class II