(104 days)
Not Found
No
The document describes a standard X-ray system with basic functions like APR and optional AEC. There is no mention of AI, ML, image processing beyond basic radiography, or any data sets for training or testing AI/ML algorithms.
No
The device is described as an X-ray system for taking diagnostic images, which means it aids in diagnosis rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is designed "for taking diagnostic images" and "Applications can be performed with the patient sitting, standing, or lying in the prone or supine position." Additionally, the "Device Description" mentions its applicability to "clinical diagnostic radiography."
No
The device description explicitly lists multiple hardware components (X-Ray generator, control console, X-Ray tube assembly, collimator, radiographic table) and describes a complete X-Ray system, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc. The tests are performed in vitro (in glass, or outside the body).
- This device is an X-ray system. It uses radiation to create images of the inside of the human body in vivo (within the living body).
The description clearly states its purpose is for taking diagnostic images of various body parts of patients, which is the function of a radiographic X-ray system, not an IVD.
N/A
Intended Use / Indications for Use
DF-211H Radiographic X-Ray system is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Product codes
KPR
Device Description
The DF-211H Radiographic X-Ray system is complete, consisting of a 50kW X-Ray generator, control console, X-Ray tube assembly, collimator, and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It has functions such as general radiography, anatomic program radiography (APR), etc. It has option of ionization chamber automatic exposure control (AEC). It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50Hz; single phase: 120V, 60 Hz; fluctuation range for voltage: 10%; the power source capacity: 50kW.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic X-Ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities and other body parts
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified/trained doctor or technician, hospitals, medical scientific research institutes, medical colleges
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)
After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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
KV20034
ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.
510(k) Summary
510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based:
- The Assigned 510(k) Number is:
-
- Submitter Information:
. Sponsor/510(k) Owner: ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. No. 16 Cuiming Road YAT-SEN Scientific Industrial Park, Tianjin Economic Technological Development Area, Tianjin 301726, China Phone: +86 22 8216 1240 Fax: +86 22 8216 0813
Dated: December 28, 2011
- · 510(k) Contact Name:
Mr. Jun Peng
P&L SCIENTIFIC, INC. 6840 SW 45TH LN #5 MIAMI, FL 33155 Phone: (305) 609 4701 Fax: (305) 397 0289 Email: jpeng@plscientificinc.com
2. Device Name
| Trade Name: | DF-211H Radiographic X-Ray system |
|---|---|
| Common Name: | System, X-Ray, Stationary |
| Classification Name: | Stationary X-Ray System |
3. Classification:
| Classification: | 21 CFR 892.1680; Class II |
|---|---|
| Product Code: | KPR |
4. Predicate Devices:
| Model | ||
|---|---|---|
| HF-50R Computer | ||
| Controlled X-Ray System | K052541 | AVANT Medical Systems |
5. Description of Device
The DF-211H Radiographic X-Ray system is complete, consisting of a 50kW X-Ray generator, control console, X-Ray tube assembly, collimator, and radiographic table. This product is applicable to clinical diagnostic radiography in all hospitals whether large or small. It has functions such as general radiography, anatomic program radiography (APR), etc. It has option of ionization chamber automatic exposure control (AEC). It is applicable to the radiography of various parts of human body. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50Hz; single phase: 120V, 60 Hz; fluctuation range for voltage: 10%; the power source capacity: 50kW.
APR 1 7 2012
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6. Intended Use
DF-211H Radiographic X-Ray system is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
7. Comparison of Technological Characteristics
The DF-211H radiographic X-ray system is similar to the predicate devices:
- . Has the same intended use and indications for use
- Utilizes the same operating principle .
- . Incorporates the same basic design
- . Incorporates the same technological characteristics
- Tested to the same electrical and electromagnetic safety standards for medical � electrical equipment
- . Manufactured under a quality system
8. Summary Performance Data
- . IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
- EN 60601-1-2:2007 (Third Edition, 2007), Medical Electrical Equipment Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic
- IEC 60601-2-7:1998 (GB 9706.3-2000 idt) Medical electrical equipment -Part 2-7: . Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
- IEC 60601-2-28:1993 (GB 9706.11-1997 idt) Medical electrical equipment Part 2-. 28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- · IEC 60601-1-3:1994 (GB 9706.12-1997 idt) Medical electrical equipment Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
- IEC 60601-2-32:1994 (GB 9706.14-1997 idt) Medical electrical equipment Part 2-. 32: Particular requirements for the safety of associated equipment of X-ray equipment
9. Conclusion
After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is safe and effective as the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font. 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
Orich Medical Equipment (Tianjin) Co., Ltd. % Mr. Jun Peng Principal Consultant P&L Scientific, Inc. 6840 SW 45th Lane #5 MIAMI FL 33155
Re: K120034
Trade/Device Name: DF-211H Radiographic X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: March 2, 2012 Received: March 7, 2012
Dear Mr. Peng:
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
APR 1 7 2012
3
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
4
Indications for Use
510(k) Number (if known): K120034
Device Name: DF-211H Radiographic X-Ray System
Indications for Use:
DF-211H Radiographic X-Ray system is designed to be used by a qualified/trained doctor or technician on adult and pediatric patients for taking diagnostic images of the skull, spinal column, chest, abdomen, extremities and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
of Radiological Ca Office of in vi lagnostic Device Evaiuation and Safety
510K K120034
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