(85 days)
No
The summary describes a standard digital radiographic system composed of existing cleared components and software, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
Explanation: The device is intended for taking diagnostic radiographic exposures, which means it is used for diagnosis, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "intended... for taking diagnostic radiographic exposures." The "Device Description" also refers to "diagnostic x-ray components."
No
The device description explicitly states it is a "new combination of already cleared solid state digital x-ray acquisition panels and software with the diagnostic x-ray components required to make a complete system." It lists various hardware components like flat panel detectors, x-ray generators, tubes, collimators, and a kerma meter. While software is part of the system, it is not the sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are used to take diagnostic radiographic exposures (X-rays) of the human body. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) diagnostic test.
- Intended Use: The intended use clearly states "taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts." This describes an imaging procedure performed directly on the patient.
Therefore, based on the provided information, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are intended for use by a qualified/ trained doctor or technician on both adult and pediatic 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 already cleared solid state digital x-ray acquisition panels and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:
- Toshiba wireless flat panel detector (FDX-3543RP, FDX-3543RPW, 14 in. x 17 in.) or Toshiba wired flat panel detector (FDX-4343R, 17 in x 17in). (K130883)
- Vieworks all series: (FXRD-1717SA/SB, or FXRD-1417SA/SB or FXRD-1417WA/WB. (K130337, Medicatech "New Series.")
- PerkinElmer XRpad™ 4336 MED, (K140551).
The purchaser can select either a "C" arm configuration (KrystalRad 1100) or an overhead tube crane configuration (KrystalRad 3000). 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. An IBA kerma meter model 120-131 is supplied. 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 and IEC 60601-1-2. The generator complies with IEC 60601-2-54.
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)
Summary of non-clinical testing: We performed integration testing. 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 and the hardware is UL Listed to US Standards for safety for medical devices (UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety standard by Underwriters Laboratories, 04/25/2003.) All of the panels comply with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Successful testing according to 60601-2-54 standard had been performed on the CPI generator.
Summary of clinical testing: Clinical images were acquired from each panel and reviewed by a board certified radiologist. The images were found to be of excellent diagnostic quality.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2015
MedicaTech USA % Daniel Kamm, P. E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K143257
Trade/Device Name: KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MOB Dated: January 13, 2015 Received: January 15, 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
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Indications for Use
510(k) Number (if known) K143257
Device Name
KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems
Indications for Use (Describe)
The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are intended for use by a qualified/ trained doctor or technician on both adult and pediatic 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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) Summary, 510(k) K143257 Submitter: MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : +1 800 817 5030 Phone : +1 949 679 2881 FAX : +1 949 679 2882 Registration Number 3004989804 Contact: George Makar, Predsident Date Prepared: August 21, 2014
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- Identification of the Device: Proprietary-Trade Name: KrystalRad 1100 and KrystalRad 3000 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
2. Equivalent legally marketed device: K133782, Sedecal Nova FA DR System, Sedecal SA.
-
- Indications for Use The KrystalRad 1100 and KrystalRad 3000 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.
-
- Description of the Device: This device represents a new combination of already cleared solid state digital x-ray acquisition panels and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:
-
Toshiba wireless flat panel detector (FDX-3543RP, FDX-3543RPW, 14 in. x 17 in.) or Toshiba wired flat panel detector (FDX-4343R, 17 in x 17in). (K130883)
-
Vieworks all series: (FXRD-1717SA/SB, or FXRD-1417SA/SB or FXRD-1417WA/WB. (K130337, Medicatech "New Series.")
-
PerkinElmer XRpad™ 4336 MED, (K140551).
The purchaser can select either a "C" arm configuration (KrystalRad 1100) or an overhead tube crane configuration (KrystalRad 3000). 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. An IBA kerma meter model 120-131 is supplied. 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 and IEC 60601-1-2. The generator complies with IEC 60601-2-54.
-
- 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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| Characteristic | Sedecal Nova FA K133782 | KrystalRad 1100 and KrystalRad 3000 |
|---|---|---|
| Intended Use: | Sedlecal "NOVA FA DR System" 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. | KrystalRad 1100 and KrystalRad 3000 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. | ||
| Configuration of | ||
| Digital Panels | Battery or AC operated wireless IEEE 802.11n | |
| or Wired Ethernet | SAME | |
| Digital Panel | ||
| Models and their | ||
| clearance | ||
| numbers | CXDI Canon Detector 401C/401C Compact | |
| (K103591) | ||
| CXDI Canon Detector 55C (K091436) | ||
| CXDI Canon Detector 501C (K111682) | 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) | ||
| Image acquisition | ||
| panel | ||
| specifications | 3,320 x 3,408 125 μm (401C) or | |
| 2,208 x 2,688 pixels 160 μm (55C) | ||
| 2,800 x 3,408 Pixels 125 μm (501C) | 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 | ||
| DICOM | DICOM 3 | DICOM 3 |
| WiFi Wireless | ||
| IEEE802.11n | ||
| (All others are | ||
| Ethernet | ||
| Tethered. | Not applicable, but compatible with all Canon | |
| panels, including wireless. | Vieworks FXRD-1417WA/WB | |
| Toshiba FDX3543RPW | ||
| PerkinElmer XRpad 4336 MED | ||
| Image acquisition | ||
| software | CANON cleared in K111682 | CrystalRad as cleared in K130377 |
| Power Source | AC Line, various voltages available | SAME |
| Photo | Image: Sedecal Nova FA K133782 | Image: Krystalrad 3000 |
| Characteristic | Sedecal Nova FA K133782 | KrystalRad 1100 and KrystalRad 3000 |
| Alternate | ||
| configuration | Sedecal X-Plus LP Plus, K090238 | |
| Image: Sedecal X-Plus LP Plus, K090238 | KrystalRad 1100 | |
| Image: KrystalRad 1100 | ||
| Generator | Sedecal SHF | CPI CMP 200DR |
| Collimator | Ralco R225A | Ralco R301A |
| Performance | ||
| Standard | FDA 21CFR1020.30-31 | SAME |
| Electrical safety | Electrical Safety per IEC-60601. UL listed | SAME |
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- Summary of non-clinical testing: We performed integration testing. 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 and the hardware is UL Listed to US Standards for safety for medical devices (UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety standard by Underwriters Laboratories, 04/25/2003.) All of the panels comply with NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set. Successful testing according to 60601-2-54 standard had been performed on the CPI generator.
- Summary of clinical testing: Clinical images were acquired from each panel and reviewed by 8. a board certified radiologist. The images were found to be of excellent diagnostic quality.
-
- Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of Medicatech USA that the "KrystalRad 1100 and KrystalRad 3000" 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. "Technological differences from the predicate device include different detectors, some with wireless functionality, a different system generator, and collimator. Although the components differ from the primary predicate device. the detectors and other components have been cleared as part of other 510(k) submissions as noted in this 510(k) Summary. Integration testing, including acquisition of phantom images, demonstrated that the hardware and software components work properly together.