The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.

Device Description

The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing. The system consists of an operator console, an image buffer section (hard disk) and control section. The operator consists of an operation CRT display that has a touch panel function, and a keyboard for entering text. An image file received from an industry-standard X-ray film cassette is processed using automatic tonal processing and is then transferred to an externally connected device including a host computer or CR printer.

AI/ML Overview

The provided 510(k) summary for the Konica Direct Digitizer REGIUS MODEL 350 primarily focuses on demonstrating substantial equivalence to a predicate device (Konica Direct Digitizer REGIUS MODEL 330) based on device description, intended use, and general specifications. It does not contain information regarding detailed acceptance criteria for diagnostic performance or a specific study proving the device meets expert-defined criteria.

This type of submission often relies on demonstrating that the new device performs fundamentally the same as a previously cleared device, rather than requiring a new clinical performance study against established ground truth.

Given the information provided, here's what can be extracted and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria related to diagnostic accuracy (e.g., sensitivity, specificity, AUC) are mentioned in this 510(k) summary. The comparison is primarily focused on technical specifications and functionality with the predicate device.

Item	Acceptance Criteria (Not explicitly stated for diagnostic performance)	Reported Device Performance (Comparison to Predicate)
Device Type	X-ray image controller using stimulative phosphor (same as predicate)	X-ray image controller using stimulative phosphor
Configuration	Reading unit + control unit (same as predicate)	Reading unit + control unit
Principle of Operation	Exposure -> Reading -> Erase using stimulable phosphor plate (same as predicate)	Exposure -> Reading -> Erase using stimulable phosphor plate
Cycle Time	Max. 25 sec. or less (for predicate)	Max. 17 sec. or less (Improved from predicate)
Exposure Size	5 sizes (for predicate)	6 sizes (Improved from predicate)
Maximum Pixels (Read)	Max. 4096 x 4924 pixel (for predicate)	Max. 4860 x 4860 pixel (Improved from predicate)
Sampling Pitch	9 types (for predicate)	2 types (Changed from predicate)
Gray Levels	4096 (same as predicate)	4096
Laser Source	Laser Diode 780nm (for predicate)	Laser Diode 690nm (Changed from predicate)
Laser Power	200mW (for predicate)	60mW (Changed from predicate)
Elevation Stroke	575mm or more (for predicate)	750mm or more (Improved from predicate)
Intended Use	Control and manage digital X-ray image file processing (same as predicate)	Control and manage digital X-ray image file processing

2. Sample size used for the test set and the data provenance

Not provided. This submission does not detail a specific diagnostic performance test set. The evaluation focuses on technical specifications and functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided. No explicit test set with ground truth established by experts is mentioned in this document.

4. Adjudication method for the test set

Not provided. As no dedicated test set for diagnostic performance is described, no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a digitizer, transforming X-ray images into digital format. It is not an AI-powered diagnostic tool that assists human readers directly. Therefore, improvement metrics with or without AI assistance are not applicable in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not an algorithm for diagnostic interpretation. The device's function is to convert X-ray film data into digital signals. The concept of "standalone performance" for diagnostic interpretation does not apply to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Since no diagnostic performance study against ground truth is described, no type of ground truth is mentioned. The evaluation is centered on the device's ability to digitize images effectively and its technical specifications compared to a predicate.

8. The sample size for the training set

Not applicable. This device is an imaging hardware component (a digitizer), not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As the device is not an AI/ML algorithm, it does not have a training set or associated ground truth.

Summary Explanation:

The 510(k) submission for the Konica Direct Digitizer REGIUS MODEL 350 focuses on establishing substantial equivalence to its predicate device (REGIUS MODEL 330) based on its technical specifications, intended use, and operational principles. The document highlights improvements in cycle time, exposure size, maximum pixels, and elevation stroke, while noting changes in sampling pitch, laser source, and laser power. Crucially, as a digitizer (a device that converts analog X-ray images to digital format), its primary function is not to perform diagnostic interpretations or assist human readers in clinical decision-making. Therefore, the typical performance metrics associated with AI/ML-driven diagnostic devices (like sensitivity, specificity, AUC, MRMC studies, or training/test sets for algorithms) are not part of this 510(k) submission. The "study" proving it meets acceptance criteria is implied through the detailed comparison of its engineering specifications against its predicate device, demonstrating that it functions robustly and safely for its intended purpose, which is to digitize X-ray images.

Summary

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510(k) Summary as required by EC7 32

K013054

1. Company Identification

MAR 4 2002

Konica Corporation

591-7,Kamihirose,Sayama-shi,Saitama-ken 350- 1.321 Japan

Tel : 011-81-42-954-4529

Fax : 011-81-42-954-6677

2. Official Correspondent

Koji Kubo (Mr.) Safety Standard Team Standards & Regulations Section Planning Department Imaging Systems Division

3. Date of Submission

August 20, 2001

4. Device Trade name

Konica Direct Digitizer REGIUS MODEL 350

5. Common Name

Film Digitizer CR /

1. Classification
  Medical image digitizer was reviewed by the Rudiology Panel and are classified in Class II per 21 CFR 892. 2030.

7. Predicate Device

Konica Direct Digitizer, Model 330, 510(k) number: K980873

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8. Description of Device

The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.

The system consists of an operator console, an image buffer section (hard disk) and control section. The operator consists of an operation CRT display that has a touch panel function, and a keyboard for entering text. An image file received from an industry-standard X-ray film cassette is processed using automatic tonal processing and is then transferred to an externally connected device including a host computer or CR printer.

For more information, please refer to the attachment.

9. Intended Use

The Konica Direct Digitizer, REGIUS MODEL 356 is an I-ray image controller which uses a Stimulative phosphor as X-ray detector and invended to control and manage digital X-ray image file processing.

10. Substantial Equivalence to Predicate Device

The Konica Direct Digitizer, REGIUS MODEL 350 is substantially equivalent to our Konica Direct Digitizer REGIUS MODEL330,510(k) number: K980873. Comparison of the principal characteristics of the wo devices which are pertinent to Specification performance is shown below.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Konica Corporation % Mr. Shinichi Yamanaka Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken 519-05 JAPAN

AUG 23 2013

Re: K013054

Trade/Device Name: Konica Direct Digitizer Regius Model 350 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 26, 2001 Received: December 3, 2001

Dear Mr. Yamanaka:

This letter corrects our substantially equivalent letter of March 2, 2002.

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, market 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (If known): Not known K 013554

Device Name: KONICA PIRCOT PICITIZER, REGIUS MODEL 350

Indications for Use:

: .

. .

The Konica Direct Digitizer, REGIUS MODEL 350 is an X-ray image controller which uses a stimulative phosphor as X-ray detector and controls and manages digital X-ray image file processing.

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

Concurrence of CDRH, Office of Device Evaluation

v Prescription Use

OR Over-The-Counter Use

(Optional Format 1-2-96)

David A. Syrom

(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices K013064
510(k) Number_

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Item	Approved Medical Device	Medical Device Applied for Approval	Remarks
Applicant, etc.	Company : Konica CorporationProduct Name : Konica Direct DigitizerREGIUS MODEL 330Approval No.: K980873	Company : Konica CorporationProduct Name : Konica Direct DigitizerREGIUS MODEL 350
Configuration	The device consists of a reading unit(the	The device consists of a reading unit(the	Same as the
	unit is combined with an elevator platform	unit is combined with an elevator platform	registered
	which horizontally positions the reading	which horizontally positions the reading	model
	device to suit to the height of the patient	device to suit to the height of the patient
	through up-and-down movement) and a	through up-and-down movement) and a
	control unit which performs the imagedisplay, image transfer, etc.	control unit which performs the imagedisplay, image transfer, etc.
Principle of	X-ray image data of a patient is	X-ray image data of a patient is	Same as the
Operation	temporarily stored in the stimulable	temporarily stored in the stimulable	registered
	phosphor plate that is contained in the	phosphor plate that is contained in the	model
	device.	device.

	After that the surface of the plate is	After that the surface of the plate is
	scanned in time sequence by laser beam so	scanned in time sequence by laser beam so
	that the amount of light according to the	that the amount of light according to the
	amount of X-ray stored in the plate is	amount of X-ray stored in the plate is
	emitted. The emitted light will be collected	emitted. The emitted light will be collected
	and converted to electric signal by a	and converted to electric signal by a
	photomultiplier tube (PMT), then to	photomultiplier tube (PMT), then to
	digital signal by an A/D converter, etc..	digital signal by an A/D converter, etc..

	After reading is completed, light of	After reading is completed, light of
	halogen lamp is applied to the surface of	halogen lamp is applied to the surface of
	the plate in order to erase the after-image.	the plate in order to erase the after-image.

	Through this chain of operations	Through this chain of operations
	(Exposure → Reading→Erase), repeat-use	(Exposure → Reading→Erase), repeat-use
	of the plate is made possible.	of the plate is made possible.
	The image data after being converted to	The image data after being converted to
	digital signal is then transferred to the	digital signal is then transferred to the
	controller and displayed on CRT.	controller and displayed on CRT.
	After checking the image, the image data	After checking the image, the image data
	will be transferred to the printer,	will be transferred to the printer,
	magneto-optic disk drive, or host	magneto-optic disk drive, or host
	computer	computer
Specifications	• Type : Exclusively for the exposure ofstand position.	• Type : Exclusively for the exposure ofstand position	Upgrated.
	• Cycle Time : Max. 25 sec. or less.(14x17in at 175 μm reading pitch)	• Cycle Time : Max. 17 sec. or less.(17x17in at 175 μm reading pitch)
	• Exposure Size : 5 sizes(14x17in, 14x14in, 11x14in, 10x12in,8x10in)	• Exposure Size : 6 sizes(17x17in, 14x17in, 14x14in, 11x14in10x12in, 8x10in )
	• Maximum Pixels(Read) :Max. 4096 x 4924 pixel	• Maximum Pixels(Read) :Max. 4860 x 4860 pixel
	• Sampling Pitch : 9 types(87.5, 100, 125, 137.5, 150, 175, 200,212.5, 350 μm)	• Sampling Pitch : 2 types(87.5, 175 μm)
	• Gray Levels : 4096• Laser Source: Laser Diode 780nm• Laser Power: 200mW• Laser Modulator; none• Elevation stroke : 575mm or more• Power Source : AC200V, 50/60Hz• Power Consumption; 1.8kW• Operational Environment :Temperature : 20~~30℃Humidity : 35~~80%RH(Applicable to reading unit only)	• Gray Levels : 4096• Laser Source: Laser Diode 690nm• Laser Power. 60mW• Laser Modulator; none• Elevation stroke : 750mm or more• Power Source : AC100/200V, 50/60Hz• Power Consumption: 1.3kW• Operational Environment :Temperature : 15~~30℃Humidity : 40~~80%RH
Purpose of Use	The device is intended for the use at theX-ray department of the hospital, etc. inorder to convert X-ray image data todigital signal and to transfer the converteddata to printer, magneto-optic disk driver,image display device, etc.	The device is intended for the use at theX-ray department of the hospital, etc. inorder to convert X-ray image data todigital signal and to transfer the converteddata to printer filing system, imagedisplay device etc.	Same as theapproved device.