(30 days)
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Not Found
No
The document describes a digital X-ray image controller and processing system without mentioning AI, ML, or related concepts.
No
The device is described as an X-ray image controller used for processing digital X-ray image files, not for treating any medical condition.
No
The device is described as an "X-ray image controller" that "controls and manages digital X-ray image file processing." It is not described as interpreting or analyzing images to provide a diagnosis or aid in diagnosis.
No
The device description explicitly states it is an "X-ray image controller which uses a Simulative phosphor as X-ray detector," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "X-ray image controller" and is used to "control and manages digital X-ray image file processing." This describes a device used for medical imaging, not for testing samples taken from the human body (which is the core function of an IVD).
- Device Description: The description reinforces the intended use, describing it as an "X-ray image controller" that uses a "Simulative phosphor as X-ray detector." This further confirms its role in capturing and processing X-ray images.
- No mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is a defining characteristic of IVDs.
Therefore, the REGIUS MODEL 370 is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing. The REGIUS MODEL 370 is NOT intended for use with digital mammography system.
Product codes
MQB
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is written in a clear, sans-serif font. The color of the logo is blue.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Koji Kuba Manager Konica Minolta Medical & Graphic, Inc. 2970 Ishkawa-cho HACHIOJI-SHI TOKYO 192-8505 JAPAN
AUG 2 3 2013
Re: K051418
Trade/Device Name: Direct Digitizer REGIUS Model 370 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 24, 2005 Received: June 1. 2005
Dear Mr. Kuba:
This letter corrects our substantially equivalent letter of July 1, 2005.
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. Drue, 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 (reporting of
1
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 requirements as set form in the quality of this. ( described in your Section 510 clargested while and to begin finding of substantial equivalence of your device to a legally marketed predication. The I Drice results in 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 CFF Parts 801 and If you desire specific advice of In Fitro Diagnostic Device Evaluation and Safety at (301) 796-007), product of 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 under the MDA regulation (21 CFR Pat 009), proday goblem/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 Tou may other 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
2
Indications for Use
510(k) Number (if known) : Kos1418
Device Name
: Direct Digitizer, REGIUS Model 370
Indications For Use:
The Direct Digitizer, REGIUS MODEL 370 is an X-ray image controller which uses a Simulative phosphor as X-ray detector and intended to control and manages digital X-ray image file processing. The REGIUS MODEL 370 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)
Nanc C. Broadon
Sign-Off
I Reproductive, Abdominal,
logical Devices
VOSULIB
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