(95 days)
No
The description focuses on the hardware components (reader, FPD, elevator stand) and the process of converting X-ray data to digital signals and transferring them. There is no mention of AI, ML, image processing beyond basic conversion, or any algorithms that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as an X-ray image reader that converts X-ray image data to digital signals. Its function is to acquire and transmit diagnostic images, not to treat or alleviate a medical condition.
No
The device is described as an X-ray image reader that converts X-ray image data to digital signals for transfer and display. Its purpose is to acquire and process image data, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is comprised of a reader and an elevator stand, which are hardware components. It also describes the reader as an X-ray image reader with a built-in FPD (Flat Panel Detector), further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for converting X-ray image data to digital signals and transferring it for display, printing, or filing. This is related to medical imaging, not the analysis of biological samples or specimens.
- Device Description: The description details an X-ray image reader with an FPD (Flat Panel Detector). This is a component of an X-ray imaging system, not a device used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's function is solely related to the acquisition and processing of X-ray images.
N/A
Intended Use / Indications for Use
The device is intended for use for medical purpose in a 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.
Flex DR C30 is not intended for use with FFDM systems.
Product codes
90 MQB
Device Description
FlexDR C30 is comprised of a reader and an elevator stand that raises and lowers the reader.
The reader is an X-ray image reader with a built-in FPD as an X-ray detector. This reader is linked to the exposure liming of the X-ray generator and starts reading of the X-ray image immediately after exposure. The read images are stored inside, and then they are converted one by one to digital data and sent to Medical Image Working Station, CS-3000, 510(k) cleared, K051523. The operator can manually adjust the height of the reader to match the height of the patient by holding the reader elevation handle at the rear of the reader.
Mentions image processing
Not Found
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
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
NOV 1 8 2008
510(k) Summary
as required by 807.92
1. Company Identification
Konica Minolta Medical & Graphic, Inc. No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan
2. Submitter's Name and Address
Koji Matsushima (Mr.) General Manager Regulation Management Division Quality Assurance Center 2970 Ishikawa-machi, Hachioji-shi, Tokyo 192-8505, Japan Telephone: 81-42-660-9607 Fax: 81-42-660-9588
3. Date of Submission
August 12, 2008
4. Device Trade Name
Digital Radiography, FlexDR C30
5. Common Name
Solld State X-ray Imager (Flat Panel / Digital Imager)
6. Classification
Class II, 21 CFR 892. 1630, Solid State X-ray Imager
7. Product Code 90 MQB
8. Predicate Device
Direct Digitizer, Regius Model 370, K051418 Canon Inc, Digital Radiography Model CXDI-40C, K031633
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9. Description of Device
FlexDR C30 is comprised of a reader and an elevator stand that raises and lowers the reader.
The reader is an X-ray image reader with a built-in FPD as an X-ray detector. This reader is linked to the exposure liming of the X-ray generator and starts reading of the X-ray image immediately after exposure. The read images are stored inside, and then they are converted one by one to digital data and sent to Medical Image Working Station, CS-3000, 510(k) cleared, K051523. The operator can manually adjust the height of the reader to match the height of the patient by holding the reader elevation handle at the rear of the reader.
10. Indications for Use
The device is intended for use for medical purpose in a hospital, etc., in order to convert X-ray image data to digital signal and to fransfer the converted data to printer, filing system, image display device, etc.
11. Substantial Equivalence to Predicate Device
The Digital Radiography, FlexDR C30 is substantially equivalent to our Direct Digitizer, Regius Model 370, K051418 and Canon Inc, Digital Radiography Model CXDI-40C, K031633. Comparison of the principal characteristics is shown in Section 4.
12. Compliance Standard
Safety standard : IEC60601-1 Ed.2(1988)+ A1(1991)+A2(1995) Electromagnetic Compatibility : IEC60601-1-2 Ed.2(2001)+A1(2004)
13. Conclusion
The Digital Radiography, FlexDR C30 has basically the same technological characteristic as the predicate devices which are approved 510(k) number: K051418 and K031633. This 510(k) has demonstrated substantial equivalence as the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Konica Minolta Medical & Graphic, Inc. % Mr. Russell Munves Official Correspondent Storch, Amini & Munves, P.C. 140 East 45th Street, 25th Floor Two Grand Central Tower NEW YORK NY 10017
AUG 2 3 2013
Re: K082347
Trade/Device Name: Flex DR C30 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 20, 2008 Received: October 22, 2008
Dear Mr. Munves:
This letter corrects our substantially equivalent letter of November 18, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered pror to thay 2018 11:12 provisions of the Federal Food, Drug, de nees may been recuire approval of a premarket approval approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, mains 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 11 your device is bluesting 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 that I DA has made a decol regulations administered by other Federal agencies. You must of any irederal statutes and regulations ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing pactice medical devioc-reated ad retor vality 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 will anow you to oogin finding of substantial equivalence of your device to a legally marketed predication. * In I Dr intention 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 If you desire specific antile of Jour aver in Viro 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 Tour may 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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Indications for Use
510(k) Number (if known) : K082347
Device Name : Flex DR C30
Indications for Use:
The device is intended for use for medical purpose in a 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.
Flex DR C30 is not intended for use with FFDM systems.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
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Division ign-Off Division of Reproductive, A Radiological Devices 510(k) Number