REGIUS CONSOLE CS-2000 and CS-3000 are KONICAMINOLTA CR CONSOLE. REGIUS CONSOLE CS-2000 and CS-3000 control and manage the direct type CR such as INDICD CONCOLL OD 2000 and Sb connected to the Control Unit and the cassette type CR such as REGIUS MODEL 170 and 190 that is connected via the network. On such as REGION INCES-3000 have the hard disk for storing the digital images. REGIUS CONSOLE CS-2000 and CS-3000 consist of a console with the touch panel function, a keyboard and a mouse for input, and a barcode scanner. It can be connected to up multiple direct type CR and multiple cassette type CR, the image read by any reader in the system will be displayed on the REGIUS CONSOLE CS-2000 and CS-3000 by which the objective cassette was registered. The image read by each reader will OD bood by in real time in synchronization with the reader operation. REGIUS CONSOLE CS-2000 and CS-3000 process the images received from the reader INDOND OD DONDOID OD 2006 and OSSS of unction, etc., and send them to the connected devices, such as the host computer or the CR printer.

AI/ML Overview

The provided text is a 510(k) summary for the REGIUS CONSOLE CS-2000 and CS-3000, which are medical image processing workstations. It states that the device is "not intended for use with digital mammography systems" and should be used by a radiographer, not for diagnosis. The documentation focuses on demonstrating substantial equivalence to a predicate device (Fuji CR Console Plus, K041990) rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial might for a new diagnostic algorithm.

Therefore, the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and MRMC studies is not explicitly present in the provided 510(k) summary. The summary highlights the device's functions and compares its features to the predicate device to establish substantial equivalence for regulatory approval.

Here's a breakdown based on the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not include a table of acceptance criteria or explicitly reported device performance metrics in the sense of accuracy, sensitivity, or specificity. The submission aims to demonstrate substantial equivalence to a predicate device by comparing features and safety, not by meeting specific performance thresholds for diagnostic accuracy.

The comparison table provided in the document focuses on hardware features and image processing functions between the applicant's device (REGIUS CONSOLE CS-2000/CS-3000) and the predicate device (Fuji Flash Plus IIP). It doesn't define acceptance criteria or report performance against them.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a test set or clinical study of this nature. The approval is based on demonstrating substantial equivalence to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. There is no mention of a test set or ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described in this 510(k) summary. The document does not mention human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not described. The device is a "Medical Image Processing Workstation" intended for use by a radiographer and explicitly states it is "never used for a diagnosis purpose." Its functions are for image processing and management, not standalone diagnosis.

7. The Type of Ground Truth Used

Not applicable. The document does not describe a clinical evaluation requiring ground truth such as pathology or outcomes data. The regulatory approach is substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set for an AI or machine learning algorithm. The device is an image processing workstation.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for this device.

Summary of Device Purpose as per 510(k):

The REGIUS CONSOLE CS-2000 and CS-3000 are medical image processing workstations designed to "Receive and process electronic images of patients." They are intended for use by radiographers to control CR systems, manage patient information, display images, and perform various image processing functions (e.g., contrast adjustment, F-processing, E-processing, H-processing, masking, rotating/flipping, re-sampling/resizing, stitching, grid suppression). Crucially, the document states: "Console is designed in the purpose that the radiographer uses and is never used for a diagnosis purpose." This clarifies that the device's function is image manipulation and management for a radiographer, not automated diagnostic interpretation.

The 510(k) approval is based on demonstrating substantial equivalence to a predicate device (Fuji CR Console Plus, K041990) by comparing hardware and software features, functionalities, and safety aspects, rather than through clinical performance studies against specific diagnostic acceptance criteria.

Summary

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K051523

510(k) Summary

as required by 807.92

1. Company Identification

JUL 2 0 2005

KONICA MINOLTA MEDICAL & GRAPHIC, INC. 2970 Ishikawa machi Hachioji-shi, Tokyo 192-8505, Japan Tel: +81-426-60-9607 Fax: +81-426-60-9588

1. Official Correspondent
  Koji Kubo(Mr.) Department TS Advanced Technology Division R & D Center
1. Date of Submission
  June 6, 2005
1. Device Trade name, Common Name
  REGIUS CONSOLE CS-2000 and REGIUS CONSOLE CS-3000, Medical Image Processing Workstation
1. Classification
  Class II, 90-LLZ, 21CFR 892.2050, Picture archiving and communications system
1. Intended Use
  Receive and process electronic images of patients
1. Applicable mandatory and voluntary standards
  REGIUS CONSOLE CS-2000 and CS-3000 comply with the following mandatory and voluntary standards:
voluntary standards.
Information Technology Equipment Part 1: General Requirements for Safety UL Standard 60950
Information Technology Equipment, Radio Disturbance (Emissions) Characteristics Limits and Methods of Measurement, IEC/CISPR 22 (EN55022)
· Information Technology Equipment, Immunity Characteristics Limits and Methods of Measurement, IEC/CISPR 24 (EN55024)
· Mcacarement, I or Shounications in Medicine) Developed by the American College of Radiology and the National Electrical Manufacturers Association
1. Description of Device

REGIUS CONSOLE CS-2000 and CS-3000 are KONICAMINOLTA CR CONSOLE.

REGIUS CONSOLE CS-2000 and CS-3000 control and manage the direct type CR such as INDICD CONCOLL OD 2000 and Sb connected to the Control Unit and the cassette type CR such as REGIUS MODEL 170 and 190 that is connected via the network.

On such as REGION INCES-3000 have the hard disk for storing the digital images.

REGIUS CONSOLE CS-2000 and CS-3000 consist of a console with the touch panel function, a keyboard and a mouse for input, and a barcode scanner.

It can be connected to up multiple direct type CR and multiple cassette type CR, the image read by any reader in the system will be displayed on the REGIUS CONSOLE CS-2000 and

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CS-3000 by which the objective cassette was registered. The image read by each reader will OD bood by in real time in synchronization with the reader operation.

REGIUS CONSOLE CS-2000 and CS-3000 process the images received from the reader INDOND OD DONDOID OD 2006 and OSSS of unction, etc., and send them to the connected devices, such as the host computer or the CR printer.

In the case that patient registration is made at each X ray room, the operator can search In the case that patient regionation information via "Examination Search Screen". the patient information of cammiliations a separate reception, the operator can display and On the ocher natia, will and information and Patient Information using "Examination List" screen. In this case, use of an ID Registration System will be necessary.

The console has the following feature.

le collook has the lonowing reasons.

The feature of subscribing patient information (the name, the age, the sexuality, the ID and so on) to display, to choose and to correct or, it is the feature to receive patient and bo only to albums), since toon (the body part, the exposures condition and so on) of the patient and to display, to choose from the hospital-information-system and to correct it.

1. The function to enter (the choice) examination information (the body part, the exposures condition and so on).
Caposares condition to specify the reading condition (the sampling pitch, the reading The fullchon to specify the reading of the image information at the Reader section.
1. The function to require the reading of the image data of the Reader section.
1. The function to receive image data from the Reader section.
o. The function to display the image data which was received from the Reader section. Image data is culled to fixed size and is displayed.
1. It temporarily saves the image data which was received from the Reader section. The feature
1. The function to do an image processing to the image data which was received from the Reader section.

The kind of the image processing

Adjusting the Contrast:

Achieve a clearly depicted image (with clear minimum density).

F-processing:

// I processins
Highlight fine detail in the image, or enhance detail that has been blurred. These process doses not affect density.

E-processing:

// 11 processing due to the wide distribution of the subject.

1. H-processing

II processing is frequency enhancement processing and equalization processing based on multi-resolution analysis.

1. Masking
  / Fills in black the area on the frame where the X-ray is not irradiated.
1. Rotating/Flipping
  Rotate/Reverse the image.
7)Re-sampling and Resizing
The function that re-samples and resizes the image data according to need.

Stitching

/ Detectings
The function that manually or automatically recognize the long body part and stitch each body part to create a composite image. The image can be divided into several small images before output to a storage device or film printer.

Note) This feature requires cassette type CR in addition connected.

9) Grid Suppression

/ The function suppresses the grid and moire patterns within the image exposed with the grid.

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1. The function to add digital marker patient information and so on to the image data which was received from the Reader section.
willch was received from the fictures boom.

The function that the printer outputs the image data which was received from the Reader section in the host computer and so on The REGIUS CONSOLE CS-2000 utilizes Discrete Cosine Transform (DCT) as of standard irreversible compression techniques to output the image data to Floppy Disk. Disa.
The REGIUS CONSOLE CS-3000 is not utilized Discrete Cosine Transform (DCT)

Note) Console is designed in the purpose that the radiographer uses and is never used for a diagnosis purpose.

1. Portable mode
  . The optional the portable mode is the practical use form which PDA(Personal Digital r ne opendial the possible it could carry a bar cord leader department and photography (condition) information from REGIUS CONSOLE CS-2000 and CS-3000 so that a bar cord can register cassette in that place in case of portable photography in the hospitalization ward and so on was used for.

9. Diagram of Layout and Interconnections

The figure of the layout and the mutual connection of the system

Image /page/2/Figure/7 description: This image shows a diagram of the CS-2/3(REGIUS CONSOLE CS-2000/3000) system. The system is connected to HIS, RIS, Printer, PACS, Viewer, Image Reader (REGIUS MODEL 170), and Konicaminolta PDAs via Ethernet (IEEE802.3*). The system is also connected to Image Reader (REGIUS MODEL 370) via Image Reader I/F (IEEE1394).

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- 1 DICOM Modality Worklist Information Model FIND
*2 DICOM Basic Grayscale Print Management Meta SOP Class
*3 DICOM Computed Radiography Image Storage DICOM Storage Commitment Push Model SOP Class
*4 Konicaminolta original protocol
*5 Konicaminolta original protocol
*6 Konicaminolta original protocol
1. Safety Information

REGIUS CONSOLE CS 2000 and CS 3000 introduce no new safety and efficacy issues other than those already identified with the predicate device. The results of a hazard analysis, than those an each fractive measure taken indicate that the device is of minor contention will as apper the May 29, 1998 issue of the "Guidance for the Content of Premark Submissions for Software Contained in Medical Devices".

1. Substantial Equivalence to Predicate Device
  The REGIUS CONSOLE CS-2000 and CS-3000 are substantially equivalent to Fuji CR Console Plus (Flash Plus IIP), 510(k) number: K041990.

Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is shown below.

1. Hardware

Feature	REGIUS CONSOLECS-3000	REGIUS CONSOLECS-2000	Fuji Flash Plus IIP
Minimum BasicComputerConfiguration	Computer "Off the Shelf"· Desktop or Tower· CPU: Pentium 4· Bus: PCI· RAM: 1GB· Hard Drive: 80GB· Floppy Drive: 3.5"· CD-ROM· Keyboard· Mouse· Barcode scanner	Computer "Off the Shelf"· Desktop or Tower· CPU: Pentium 4· Bus: PCI· RAM: 512MB· Hard Drive: 80GB· Floppy Drive: 3.5"· CD-ROM· Keyboard· Mouse· Barcode scanner	Computer "Off the Shelf"· Desktop or Tower· CPU: Pentium 4· Bus: ISA/PCI· RAM: 512MB· Hard Drive: 40GB· Floppy Drive: 3.5"· CD-ROM· Keyboard· Mouse· Barcode scanner
Operating SystemSoftware	Microsoft Windows XP	Microsoft Windows XP	Microsoft Windows 2000or Windows XP
Ethernet Capability &Type	Yes:LAN	Yes:LAN	Yes:LAN
Image transfer	via DICOM 3.0 &Via proprietary protocol	via DICOM 3.0 &Via proprietary protocol	via DICOM 3.0 &Via Fuji DMS Network
Image Display	15" color 1MP LCDwith Touch screen	15" color 1MP LCDwith Touch screen	19" color 2MP LCDwith Touch screen
Image processingfunctions	Yes, enhanced	Yes, enhanced	Yes, enhanced
Image viewing &orientation functions	Yes, enhanced	Yes, enhanced	Yes, enhanced
Connects toKonicaminoltaImage Readers	Yes	Yes	No
Connects toKonicaminoltaImageRecorders(Printers)	Yes	Yes	Yes
Connects toKonicaminoltaPDAs(The option forportable mode)	Yes	No
Feature	REGIUSCONSOLECS-3000	REGIUSCONSOLECS-2000	Fuji Flash Plus IIP
Imageprocessing	a. F-processingF-Processing is a form of image processing whichmodifies image spatial frequency characteristics, sothat structures of body parts are displayed moresharply.		a. Gradation/Edge enhancementAlong with gradation, edge enhancement aswell as DRC Fuji image processing makes imagequality consistently good, so the technologistspends less time manipulating the image.	Same astheapproveddevice
	b. E-processingE-processing allows an image with a wide dynamicrange to be converted to one with a smallerdynamic range which is easier to view.		b. DRC (Dynamic Range Control)DRC improves visualization of areas withdifferent densities in the same image.	Same astheapproveddevice
	c. H-processingH-Processing is the method of frequencyProcessing that uses the resolution of the imagein multi resolution space. This adjusts thesharpness of the image and compress the dynamicrange.		c. MFP(Multi-objective Frequency Processing)MFP enables enhancement of both small andlarge structures at the same time as well asbetter visualization of areas with differentdensities.	Same astheapproveddevice
	d. Grid SuppressionThe function suppresses the grid and moirepatterns within the image exposed with the grid,processing by filtering.		d. GPR (Grid Pattern Removal)GPR removes stationary grid pattern tosuppress moire patterns within an image.	Same astheapproveddevice
	e. MaskingMasking blacks out areas outside the field of X-rayexposure on the image.			Additionalfeature
	f. Re-sampling and ResizingThe functions change the resolution of the image,using digital image interpolation according to need.			Additionalfeature
	g. StitchingStitching assembles the composite image from theimages read out the photostimulated luminescenceplates which had been positioned such that the twoadjacent plates overlap each other at the exposure.This manually or automatically adjusts the imagepositions which are matched with each other.			Additionalfeature

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2) Software

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a bird or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Konica Minolta Medical & Graphic, Inc. % Mr. Shinishi Yamanaka Safety Department Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun Mie-ken, 519-05 JAPAN

Re: K051523

JUL 2 0 2005

Trade/Device Name: Medical Image Processing Workstation, REGIUS CS-2000/CS-3000 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 6, 2005 Received: June 14, 2005

Dear Mr. Yamanaka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, not the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with the Act's requirements, including, but not limited to registration and listing (21 CFR Port 807) vian ing (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) : Қ ( 6 ﻛ

Device Name

Medical Image Processing Workstation, REGIUS CS-2000/ .. CS-3000
Indications For Use:

Receive and process electronic images of patients. The REGIUS CS-2000/CS-3000 is NOT intended for use with digital mammography system.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)

of Reproductive, Abdominal, diological Devices 510(k) Number

Page 1 of

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).