KONICA DIRECT DIGITIZER REGIUS MODEL 350

• K Number: K013054
• Device Name: KONICA DIRECT DIGITIZER REGIUS MODEL 350
• Manufacturer: KONICA MINOLTA MEDICAL & GRAPHIC, INC.
• Date Cleared: 2002-03-01 ( 171 days)
• Product Code: MQB
• Regulation Number: 892.1680

Intended 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.

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.

Predicate Devices

K980873

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard digital image processing and control, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is an X-ray image controller and digitizer, not a device used for treating disease or maintaining health.

Diagnostic

No
The device is an X-ray image controller that processes and manages digital X-ray image files. It does not provide a diagnosis itself, but rather processes the images that a healthcare professional would then use for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as an operator console, image buffer section (hard disk), control section, CRT display, and keyboard, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Konica Direct Digitizer, REGIUS MODEL 350 is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• The Konica Direct Digitizer processes X-ray images. X-ray imaging is an in vivo (within the living body) diagnostic technique, not an in vitro technique.
• The device description clearly states it uses a stimulative phosphor as an X-ray detector and controls and manages digital X-ray image file processing. This is consistent with medical imaging equipment, not IVD equipment.

Therefore, the device falls under the category of medical imaging equipment, not IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

MQB

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

X-ray department of the hospital, etc.

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.

K980873

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

§ 892.1680 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.

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 : [phone]

Fax : [phone]

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 /

• 6. 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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Item	Approved Medical Device	Medical Device Applied for Approval	Remarks
Applicant, etc.	Company : Konica Corporation
Product Name : Konica Direct Digitizer
REGIUS MODEL 330
Approval No.: K980873	Company : Konica Corporation
Product Name : Konica Direct Digitizer
REGIUS 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 image
display, image transfer, etc.	control unit which performs the image
display, 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 of
stand position.	• Type : Exclusively for the exposure of
stand 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, 11x14in
10x12in, 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 the
X-ray department of the hospital, etc. in
order to convert X-ray image data to
digital signal and to transfer the converted
data to printer, magneto-optic disk driver,
image display device, etc.	The device is intended for the use at the
X-ray department of the hospital, etc. in
order to convert X-ray image data to
digital signal and to transfer the converted
data to printer filing system, image
display device etc.	Same as the
approved device.

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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

5

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 [phone]. 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 [phone] or [phone] 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_