Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004363352

FEI Number

3004363352

Entity Name

MIM SOFTWARE INC.

City/State/Country

Cleveland, OH, US

Establishment Address

25800 Science Park Dr Ste 180, Cleveland, OH 44122, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

MIM Software Inc. (Owner Number: 9057943)

Owner / Operator Contact Address

25800 Science Park Drive, Suite 180, Cleveland, OH 44122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052379

PMA Number

N/A

All Registered Proprietary Names

VueMe MIMcloud MIM- Symphony HDR Fusion Symphony HDR MIM-Symphony HDR Contour ProtegeAI Contour ProtegeAI Contour ProtegeAI+ MIM Encore MIM Maestro MIMpacs MIM 3D US Contour ProtegeAI (2 models) MIM MIM-Thin Client (mobile) MIM-LesionID Pro LesionID Pro Contour ProtegeAI (3 and 3.1 models) MIM-Dose Analysis Contour ProtegeAI (4 models) CPAI+ Contour ProtegeAI+ MIM Symphony DxLite MIM Symphony LDR MIM Symphony Dx MIM Symphony Bx CPAI+ Contour ProtegeAI+ MIMneuro MIM SurePlan MRT MIM SPECTRA Quant MIM SPECTRA Recon MIMcardiac MIMfusion

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2011-02-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2020-10-07
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2024-02-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-02-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-05-14
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2023-06-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-10-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-02
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2022-10-11
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-05-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-05-22
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-05-22
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2023-06-07
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2026-04-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-05-24
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2026-04-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-05-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-10-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2005-12-27

Official Correspondent

Shekhar Ganore

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MIM Software Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004363352. Last updated year: 2026. Please use registration number 3004363352 when referencing this establishment in official correspondence.