(252 days)
Not Found
No
The document describes standard image processing capabilities but does not mention AI, ML, or related terms like deep learning or neural networks.
No.
The device is used for imaging (fluoroscopic and radiographic imaging) during diagnostic, surgical, and interventional procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to provided fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures." The inclusion of "diagnostic" directly indicates its use in diagnosing conditions.
No
The device description explicitly states it is a "C-arm X-ray mobile system" consisting of hardware components like a C-arm stand base, monitor trolley, X-ray generator, X-ray tube assembly, image intensifier, and CCD camera. While it includes image processing software, it is an integral part of a larger hardware system.
Based on the provided information, the KMC-950 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures." This involves imaging inside the patient's body, not testing samples outside the body.
- Device Description: The description details a C-arm X-ray system, which is a medical imaging device used on living patients. It involves X-ray generation, image intensification, and display of images of the patient's internal structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The KMC-950's function is entirely focused on generating and displaying images of the patient's internal anatomy.
N/A
Intended Use / Indications for Use
The KMC-950 C-arm X-ray mobile system is used to meet the radiographic and fluoroscopic image & visualization required in surgical, orthopedic and emergency room operation.
The fluoroscopic mode of operation allows the attending physician to see the image directly on the TV monitor in real time without the need to develop individual lilms.
The KMC-950 is intended to provided fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.
The system may be used for other RF imaging application at physician's discretion.
Product codes (comma separated list FDA assigned to the subject device)
JAA, OWB, OXO
Device Description
The KMC-950 is a C-arm X-ray mobile systems consisting of a C-arm stand base and monitor trolley. The C-arm mobile stand holds the high-frequency X-Ray generator, X-ray tube assembly, X-ray controls, image intensifier and CCD camera.
Monitor trolley supports the image display TV monitors, image processing and recording devices.
KMC-950 are providing a dynamic motion images on the TV monitor in such principles of lower dosage, better image quality and digital manipulation, workflow enhancement, operator and patient comfort and versatility.
A general radiographic stationary images are able to produce on x-ray film. Therefore a cassette holder is provided with the mobile system.
Mentions image processing
Monitor trolley supports the image display TV monitors, image processing and recording devices.
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
surgical, orthopedic and emergency room operation
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)
Results of performance and compliance testing conducted at manufacturing facility and independent test organization on KMC-950 C-arm mobile systems, indicates conformance to all applicable performance standards promulgated by FDA for these systems.
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.
K 021049, K 973598, K993896, K022114
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).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Ko32761
Fuje lış
Image /page/0/Picture/1 description: The image shows the logo for United Radiology Systems, Inc. The logo consists of a stylized graphic to the left of the company name. Below the company name is the address "151 South Pfingsten Road, Unit T".
Deerlield, Illinois 60015
Tel: 847-291-0999 Fax: 847-291-1090 ww.united-radiology.com
HAY 1 4 2004
510(k) SUMMARY FOR KMC-950 C-ARM MOBILE X-RAY UNIT
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87 (a) to (h).
1.0. Identification of submitter
United Radiology Systems, Inc 151 S. Pfingsten Road, Unit T Deerfleid, IL 60015
Establishment Registration No. : # 1424287 Corresponding official : John W. Lee / President
2.0. Identification of Product
Trade / Model Name : KMC-950, C-arm Mobile Panel : X-Ray System Classification : Class II
Product Code : Fluoroscopic, Image Intensified ( 90 JAA)
Regulation No. : 21 CFR 892. 1650/ Product code : 90 JAA ر/WB, OXO
Manufacturer : COMED Medical Systems, Inc. 58 Hak-Dong, Chowol-Myun, Kwangju-Shi, Kyunggi- Do South Korea
3.0. Reason for 510 (k) PMN Submission
KMC-950, C-arm mobile is new X-ray mobile systems.
4.0. Product Description
The KMC-950 is a C-arm X-ray mobile systems consisting of a C-arm stand base and monitor trolley. The C-arm mobile stand holds the high-frequency X-Ray generator, X-ray tube assembly, X-ray controls, image intensifier and CCD camera.
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K03276d
page 3
Monitor trolley supports the image display TV monitors, image processing and recording devices.
KMC-950 are providing a dynamic motion images on the TV monitor in such principles of lower dosage, better image quality and digital manipulation, workflow enhancement, operator and patient comfort and versatility.
A general radiographic stationary images are able to produce on x-ray film. Therefore a cassette holder is provided with the mobile system.
6.0. Intended Use :
The KMC-950 C-arm X-ray mobile system is used to meet the radiographic and fluoroscopic image & visualization required in surgical, orthopedic and emergency room operation.
The fluoroscopic mode of operation allows the attending physician to see the image directly on the TV monitor in real time without the need to develop individual lilms.
6.0. Equivalent Devices :
The KMC-950 C-arm X-ray mobile systems are substantially equivalent to a legally marketed predicate devices and 510(k) numbers with regard to safely and effectiveness as following list :
- ◆ GE OEC 9800 PLUS : K 021049
-
- Siemens, Siremobile ISO-C : K 973598
- ◆ Medison Acoma, MCA-6100 : K993896 -
-
- ELMSTech. IMPERIUM : K022114
7.0. Performance Standards :
The KMC-950 is designed in accordance with the national and intemational product safety and performance requirements established in the following standards :
-
- 21 CFR 1020.30-32 : Federal Performance Standard for Diagnostic X-rav Systems.
-
- IEC 60601-1-1 : Medical Electrical Equipment- Part 1. General Requirements for Safety 1 & 2
-
- IEC 60601-1-2 : Medical Electrical Equipment Part 1.
- . General Requirements for Safety- 2
- Collateral Standard / Electromagnetic ー
- Compatibility- Requirements & Test
- IEC 60601-1-2 : Medical Electrical Equipment Part 1.
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Kosztoi
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- ◆ IEC 60601-1-3 : Medical Electrical Equipment- Part 1
- General Requirement for safety -3 "
- Collateral Standard / General requirement -For radiation protection in diagnostic x-ray equipment.
-
- IEC 60601-2-7 : Medical Electrical Equipment- Part 2, Particular Requirements for the safely of high voltage of diagnostic x-ray generators
- IEC 60601-2-28 Medical Electrical Equipment, X-ray tubes and � X-ray Source Assemblies
- IEC 60601-2-32 Medical Electrical Equipment, Part 2 Particular � Requirements for the Safely of associated devices of X-ray equipment .
Results of performance and compliance testing conducted at manufacturing facility and independent test organization on KMC-950 C-arm mobile systems, indicates conformance to all applicable performance standards promulgated by FDA for these systems.
8.0. Component & Material
Certifiable Component List
| General Description | Component / Model Designation |
|---|---|
| X-ray Controller | KMC-950-HFG-C |
| High Tension Transformer | KMC-950-HTT |
| Image Intensifier Tube | TH-9466 |
| X-ray Tube | KMC-950-RAD-99 |
| Collimator | KMC-950-CM-4MR |
- Appendix & Attachment : 9.0.
- A. Product Comparison List
- Product Identification & Labels B.
- PMN Truthful & Accurate Statement C.
- D. Premarket Notification 510(k) Statement
- E. Software Validation & Verification
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, repeated three times to create a sense of depth and connection. The figures are rendered in blue. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 22 2012
Mr. John W. Lee President United Radiology Systems. Inc. 151 South Pfingsten Road, unit T DEERFIELD IL 60015
Re: K032761
Trade/Device Name: KMC-950 C-Arm Mobile System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, and JAA Dated: April 23. 2004 Received: April 27, 2004
Dear Mr. Lee:
This letter corrects our substantially equivalent letter of November 14, 2011.
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 (reporting of
4
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/ReportalProblem/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
5
STATEMENT OF INTENDED USE
510 (k) Number ( If known) : - Notknown K-03276 I Device Name : KMC-950 C-arm Mobile System
INDICATIONS OF USE :
The KMC-950 is intended to provided fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.
The system may be used for other RF imaging application at physician's discretion.
( Please do not write below this line – continue on the another page if needed )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ Use
Over- The - Counter -OR
( Per 21 CFR 801.109 )
Daniel A. Lyman
Division Sien-Off 510(k) Number
( Optional Format 1-2-9)