Facility

MIM SOFTWARE INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004363352
Establishment type	Manufacture Medical Device
Location	25800 Science Park Dr Ste 180 Cleveland, OH, US 44122
Registration status	Active · expires 2026
Parent company	MIM Software Inc. (owner-operator 9057943)
Brand names	CPAI+; Contour ProtegeAI+

Activity by year

Recalls (1)

Devices registered here (1)

Radiological Image Processing Software For Radiation Therapy
Product code QKB (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IIOngoing2025-02-19
In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.

All facilities operated by MIM Software Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MIM SOFTWARE INC. (FEI 3004363352) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004363352-mim-software-inc/

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