(89 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on standard radiographic components and software integration.
No
The device is described as a "Digital Stationary Radiographic System" intended for "taking diagnostic radiographic exposures," which indicates its use for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "intended for use... for taking diagnostic radiographic exposures". The "Device Description" also refers to "diagnostic x-ray components".
No
The device description explicitly lists multiple hardware components including a digital x-ray acquisition panel, x-ray generator, x-ray tubes, and collimator, indicating it is a complete hardware system with integrated software, not a software-only 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 taking "diagnostic radiographic exposures" of various body parts. This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details components like an X-ray acquisition panel, X-ray generator, X-ray tubes, and collimator. These are all components of an X-ray imaging system.
- Input Imaging Modality: The input modality is "Radiographic," which is a form of medical imaging, not an in vitro diagnostic test.
- Anatomical Site: The device is used to image specific anatomical sites within the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
The device described is a medical imaging device used for diagnostic purposes in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
N/A
Intended Use / Indications for Use
The Models 2200DR and 1600DR Digital Stationary Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures 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. Not for mammography.
Product codes
KPR, MOB
Device Description
This device represents a new combination of an already cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray compnents required to make a complete system. The digital panel is the Toshiba wired flat panel detector FDX-4343R, 17 in x 17in. (Cleared in K 143257 as well as other submissions.) The system has been tested with only this model of flat panel detector. The purchaser can select either a "C" arm configuration (1600DR) or an overhead tube crane configuration (2200DR). The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1-2, and IEC60601-2-54. The systems include an AEC feature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic exposures (X-ray)
Anatomical Site
skull, spinal column, chest. abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
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)
Non-clinical testing: integration testing and risk analysis.
Summary of non-clinical testing: We performed integration testing and risk analysis. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards. The device conforms to this list of voluntary standards:
Standards No. 60601-1, Standards Organization IEC, Standards Title Safety of Electrical Medical Equipment, Version 2005 + A1 (2012), Date 2005 + A1 (2012)
Standards No. 60601-1-2, Standards Organization IEC, Standards Title Electromagnetic Compatibility, Version 2007, Date 2007
Standards No. 60601-2-54, Standards Organization IEC, Standards Title Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy, Version 2009 1ed, Date 2009
Standards No. PS 3.1 - 3.18 (2009), Standards Organization NEMA, Standards Title Digital Imaging and Communications in Medicine (DICOM) Set (This applies to the Digital Panel), Version 3, Date 2009
Clinical testing: Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (e.g., use of previously cleared detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2015
Beijing Polycon Medical Engineering Company % Daniel Kamm, P.E. Principal Engineer Kamm and Associates 8870 Ravello Court NAPLES FL 34114
Re: K151219
Trade/Device Name: Models 2200DR and 1600DR Digital Stationary Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: June 24, 2015 Received: June 30, 2015
Dear Mr. Kamm:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151219
Device Name
Models 2200DR and 1600DR Digital Stationary Radiographic Systems
Indications for Use (Describe)
The Models 2200DR and 1600DR Digital Stationary Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures 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. Not for mammography.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) Summary, 510(k) K151219 Submitter: Beijing Polycon Medical Engineering Company Building 9, Fu Wai Liang Jia Dian Street Hai Dian Qu , Beijing 100142, P.R. China Tel: 8610-8811-0881 Fax: 8610-88148957 Date Prepared: June 13, 2015 Contact: Xiangchen Liu, President
1. Identification of the Device:
Proprietary-Trade Name: Models 2200DR and 1600DR Digital Stationary Radiographic Systems Classification Name: Stationary X-Ray System, Product codes KPR and MQB Common/Usual Name: Digital Diagnositc X-Ray System Device Class: II per regulation 21CFR892.1680
-
- Equivalent legally marketed device: KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems, K143257, MedicaTech USA. Classification Name: Stationary X-Ray System. Product codes KPR and MOB Common/Usual Name: Digital Diagnositc X-Ray System Device Class: II per regulation 21CFR892.1680
- Indications for Use The Models 2200DR and 1600DR are intended for use by a qualified/trained doctor or 3. technician on both adult and pediatric subjects for taking diagnostic radiographic exposures 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. Not for mammography.
- Description of the Device: This device represents a new combination of an already cleared solid state digital 4. x-ray acquisition panel and software with the diagnostic x-ray compnents required to make a complete system. The digital panel is the Toshiba wired flat panel detector FDX-4343R, 17 in x 17in. (Cleared in K 143257 as well as other submissions.) The system has been tested with only this model of flat panel detector. The purchaser can select either a "C" arm configuration (1600DR) or an overhead tube crane configuration (2200DR). Please see the photos below. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1-2, and IEC60601-2-54. The systems include an AEC feature.
-
- Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels and software.
-
- Substantial Equivalence Chart: Please see the next page.
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| Characteris
tic | KrystalRad 1100 and
KrystalRad 3000 Digital
Stationary Radiographic
Systems, K143257,
MedicaTech USA. | Models 2200DR and 1600DR
Digital Stationary
Radiographic Systems,
Beijing Polycon Medical
Engineering Company | Difference and Analysis |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use: | KrystalRad Series is intended
for use by a qualified/trained
doctor or technician on both
adult and pediatric subjects for
taking diagnostic radiographic
exposures 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.
Not for mammography. | Models 2200DR and 1600DR
Digital Stationary
Radiographic Systems are
intended for use by a
qualified/trained doctor or
technician on both adult and
pediatric subjects for taking
diagnostic radiographic
exposures 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.
Not for mammography.
(SAME) | NO DIFFERENCE |
| Configurati
on of
Digital
Panels | Battery or AC operated
wireless IEEE 802.11n or
Wired Ethernet | AC operated Wired Ethernet
only. | Difference: There is no
chance of wireless
interference with the Polycon
implementation. |
| Digital
Panel
Models and
their
clearance
numbers | Vieworks/Medicatech
FXRD-1717SA/SB,
FXRD-1417SA/SB and
FXRD-1417WA/WB
(K130337)
Toshiba: FDX4343R/RPW,
FDX3543RP and
FDX3543RPW (Del Medical:
K140825; O&R: K131121;
Sedecal: K130883);
PerkinElmer: XRpad 4336
MED (K140551) | Toshiba: FDX4343R
Cleared in the Predicate
Device, K143257 | NO DIFFERENCE |
| Image
acquisition
panel
specificatio
ns | FXRD-1717SA/SB: 3,072 x
3,072, 140μm
FXRD-1417SA/SB: 2560 x
3072, 140μm
FXRD-1417WA/WB: 2560 x
3072, 140μm
FDX4343R/RPW:
3008×3072, 143 μm
FDX3543RP: 2448×2984, 143
μm
FDX3543RPW: 2466×3040,
140μm
XRpad 4336 MED:
3556×4320, 100 μm | FDX4343R 3008×3072, 143
μm | NO DIFFERENCE |
| Characteris
tic | KrystalRad 1100 and
KrystalRad 3000 Digital
Stationary Radiographic
Systems, K143257,
MedicaTech USA. | Models 2200DR and 1600DR
Digital Stationary
Radiographic Systems,
Beijing Polycon Medical
Engineering Company | Difference and Analysis |
| AEC | YES | YES | NO DIFFERENCE |
| DICOM | DICOM 3 | DICOM 3 | NO DIFFERENCE |
| Image
acquisition
software | CrystalRad as cleared in
K130377 | ECOM Software | DIFFERENT SOFTWARE:
Software was as cleared in:
K130883. That submission
used the same Toshiba panel,
FDX4343R We verified
proper operation of the
ECOM software via Clinical
Testing. |
| Power
Source | AC Line, various voltages
available | SAME | NO DIFFERENCE |
| Photo | Krystalrad 3000 | 2200DR | NO DIFFERENCE |
| Alternate
configurati
on | KrystalRad 1100 | 1600DR | NO DIFFERENCE |
| Generator | CPI CMP 200DR | CPI CMP 200DR | NO DIFFERENCE |
| Collimator | Ralco R302A | Ralco R302A | NO DIFFERENCE |
| Tube Head | Toshiba | Toshiba | NO DIFFERENCE |
| Performance
Standard | FDA 21CFR1020.30-31 | SAME | NO DIFFERENCE |
| Electrical
safety | Electrical Safety per IEC-60601.
UL listed | SAME | NO DIFFERENCE |
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6
- Summary of non-clinical testing: We performed integration testing and risk analysis. The results of a 7. review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards. The device conforms to this list of voluntary standards:
| Standards
No. | Standards
Organization | Standards Title | Version | Date |
|-------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------|
| 60601-1 | IEC | Safety of Electrical Medical Equipment | 2005 + A1
(2012) | 2005 + A1
(2012) |
| 60601-1-2 | IEC | Electromagnetic Compatibility | 2007 | 2007 |
| 60601-2-54 | IEC | Particular requirements for the basic safety and
essential performance of X-ray equipment for
radiography and radioscopy | 2009 1ed | 2009 |
| PS 3.1 - 3.18
(2009) | NEMA | Digital Imaging and Communications in
Medicine (DICOM) Set (This applies to the
Digital Panel) | 3 | 2009 |
-
- Summary of clinical testing: Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (e.g., use of previously cleared detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
-
- Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Beijing Polycon that the "Models 2200DR and 1600DR Digital Stationary Radiographic Systems" are as safe and effective as the predicate device, have few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.