Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on image processing and console functionality, with no mention of AI or ML terms or related concepts like training/test sets.

Therapeutic

No
The device is described as a console that receives, processes, and manages electronic images, and sends them to connected devices. It does not perform any direct therapeutic action on a patient.

Diagnostic

No

The device is a console that processes and manages electronic images from CR systems, sending them to connected devices like host computers or printers. It does not perform diagnostic functions itself; rather, it handles the images that would then be reviewed by a radiographer for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a console with a touch panel, keyboard, mouse, and barcode scanner, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "Receive and process electronic images of patients." This describes a system for handling medical images, not for performing tests on biological samples to diagnose diseases or conditions.
Device Description: The description details a console for managing and processing images from Computed Radiography (CR) systems. It focuses on image handling, storage, and transmission, not on analyzing biological specimens.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.

The device is clearly a medical imaging processing and management system, which falls under a different regulatory category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Receive and process electronic images of patients.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

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.

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.

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.
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.
The function to require the reading of the image data of the Reader section.
The function to receive image data from the Reader section.
The function to display the image data which was received from the Reader section. Image data is culled to fixed size and is displayed.
It temporarily saves the image data which was received from the Reader section. The feature
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:

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

E-processing:

II processing due to the wide distribution of the subject.

H-processing
II processing is frequency enhancement processing and equalization processing based on multi-resolution analysis.
Masking
Fills in black the area on the frame where the X-ray is not irradiated.
Rotating/Flipping
Rotate/Reverse the image.
Re-sampling and Resizing
The function that re-samples and resizes the image data according to need.
Stitching

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.

Grid Suppression

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

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

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

radiographer / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041990

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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

1

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.

2

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).

*6

3

- 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 CONSOLE
CS-3000 | REGIUS CONSOLE
CS-2000 | Fuji Flash Plus IIP | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Minimum Basic
Computer
Configuration | 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 System
Software | Microsoft Windows XP | Microsoft Windows XP | Microsoft Windows 2000
or 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 LCD
with Touch screen | 15" color 1MP LCD
with Touch screen | 19" color 2MP LCD
with Touch screen | |
| Image processing
functions | Yes, enhanced | Yes, enhanced | Yes, enhanced | |
| Image viewing &
orientation functions | Yes, enhanced | Yes, enhanced | Yes, enhanced | |
| Connects to
Konicaminolta
Image Readers | Yes | Yes | No | |
| Connects to
Konicaminolta
Image
Recorders(Printers) | Yes | Yes | Yes | |
| Connects to
Konicaminolta
PDAs(The option for
portable mode) | Yes | No | | |
| Feature | REGIUS
CONSOLE
CS-3000 | REGIUS
CONSOLE
CS-2000 | Fuji Flash Plus IIP | |
| Image
processing | a. F-processing
F-Processing is a form of image processing which
modifies image spatial frequency characteristics, so
that structures of body parts are displayed more
sharply. | | a. Gradation/Edge enhancement
Along with gradation, edge enhancement as
well as DRC Fuji image processing makes image
quality consistently good, so the technologist
spends less time manipulating the image. | Same as
the
approved
device |
| | b. E-processing
E-processing allows an image with a wide dynamic
range to be converted to one with a smaller
dynamic range which is easier to view. | | b. DRC (Dynamic Range Control)
DRC improves visualization of areas with
different densities in the same image. | Same as
the
approved
device |
| | c. H-processing
H-Processing is the method of frequency
Processing that uses the resolution of the image
in multi resolution space. This adjusts the
sharpness of the image and compress the dynamic
range. | | c. MFP(Multi-objective Frequency Processing)
MFP enables enhancement of both small and
large structures at the same time as well as
better visualization of areas with different
densities. | Same as
the
approved
device |
| | d. Grid Suppression
The function suppresses the grid and moire
patterns within the image exposed with the grid,
processing by filtering. | | d. GPR (Grid Pattern Removal)
GPR removes stationary grid pattern to
suppress moire patterns within an image. | Same as
the
approved
device |
| | e. Masking
Masking blacks out areas outside the field of X-ray
exposure on the image. | | | Additional
feature |
| | f. Re-sampling and Resizing
The functions change the resolution of the image,
using digital image interpolation according to need. | | | Additional
feature |
| | g. Stitching
Stitching assembles the composite image from the
images read out the photostimulated luminescence
plates which had been positioned such that the two
adjacent plates overlap each other at the exposure.
This manually or automatically adjusts the image
positions which are matched with each other. | | | Additional
feature |

4

2) Software

:

5

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.

6

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

7

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

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