(281 days)
No
The description focuses on the hardware (flat panel detector) and basic image processing software, with no mention of AI, ML, or related concepts.
No.
This device is an x-ray detector used for image acquisition and processing, not for treating any medical conditions.
No
This device is a flat panel x-ray detector that captures digital images. It is used to acquire images for diagnostic purposes, but it does not perform the diagnosis itself; it is a tool for image acquisition, not diagnosis.
No
The device description clearly states it consists of "a line of 3 different models of solid state x-ray detectors" which are hardware components (tethered and wireless panels). While it includes software, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ClearVision ExamVue Flat Panel Detector is an imaging device that captures digital x-ray images of the human anatomy. It works by converting x-rays into electronic signals, not by analyzing biological specimens.
- Intended Use: The intended use clearly states it's for acquiring digital x-ray images in various radiology settings.
- Device Description: The description details the hardware (flat panel detector) and software used for image acquisition, processing, and storage. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the ClearVision ExamVue Flat Panel Detector is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format.
All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:
a. A 14x17in (35x43cm) tethered cassette sized panel
b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection
c. A 17x17in (43x43cm) tethered panel for fixed installations.
Mentions image processing
The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
The LTX240AA01-A digital flat panel X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children.
Intended User / Care Setting
radiologists and radiology technicians
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)
Bench tests reports have been provided, detailing the safety and EMC testing, as well as non-clinical performance data for the ClearVision ExamVue Flat Panel Detector.
Biocompatibility data has been provided for patient-contacting surfaces of the device, demonstrating that there are no known adverse reactions to skin contact with the device.
We have also provided clinical testing of the hardware, showing comparison images using identical software, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limiting Resolution:
3.7lp/mm (ExamVue FPD FDX3543RP)
3.7lp/mm (Examvue FPD FDX3543RPW)
3.7lp/mm (Examvue FPD FDX4343R)
Over 3lp/mm (ATAL-8)
3lp/mm (LTX240AA01-A)
DQE @ 1 lp/mm:
57% (ExamVue FPD FDX3543RP)
60% (Examvue FPD FDX3543RPW)
58% (Examvue FPD FDX4343R)
33% Gadox / 46% CsI (ATAL-8)
45% Gadox / 65% CsI (LTX240AA01-A)
MTF @ 1 lp/mm:
63% (ExamVue FPD FDX3543RP)
68% (Examvue FPD FDX3543RPW)
65% (Examvue FPD FDX4343R)
63% Gadox / 72% CsI (ATAL-8)
57% Gadox / 59% CsI (LTX240AA01-A)
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.
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.
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of three human profiles facing to the right, with a stylized caduceus-like symbol above them. The design is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
JPI Healthcare, Inc. % Mr. William Little Senior Product Manager JPI Healthcare Solutions, Inc. 52 Newtown Plaza PLAINVIEW NY 11803
Re: K160143
Trade/Device Name: ClearVision Exam Vue Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 12, 2016 Received: September 13, 2016
Dear Mr. Little:
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.
Michael D'Hara For
Robert Ochs, Ph.D. 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) K160143
Device Name
ClearVision ExamVue Flat Panel Detector
Indications for Use (Describe)
The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510 (k) Summary
August 10, 2016.
-
- Company and Correspondant Making the Submission:
Name: JPI Healthcare Co., LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: +82-2-2108 - 2580 (Ext. 500-504) Fax: +82-2-2108-1180 Contact: John Lim Website: http://www.jpi.co.kr/
- Company and Correspondant Making the Submission:
-
- Identification of Device
| Classification Name: | Solid State X-ray Imager (flat panel/digital imager) |
|---|---|
| Common Name: | Solid State X-ray Imager |
| Trade/Proprietary Name: | ClearVision ExamVue Flat Panel Detector |
3. Predicate Device
| Manufacturer: | Atlaim |
|---|---|
| Device: | ATAL-8 |
| 510(k) Number: | K113812 |
| Classification Name: | Solid State X-ray Imager (flat panel/digital imager) |
| Common Name: | Solid State X-ray Imager |
| Regulatory Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | 90 MQB |
| Manufacturer: | Samsung Mobile Display |
|---|---|
| Device: | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL |
| LTX240AA01-A | |
| 510(k) Number: | K090742 |
| Classification Name: | Solid State X-ray Imaging Device |
| Common Name: | Digital Flat Panel Xray Detector |
| Regulatory Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | 90 MQB |
4
- Product Classification Names and Citations 4.
Regulatory Number: 21 CFR 892.1680 Regulatory Class: II Product Code: 90 MQB
5. Description:
The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format.
All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:
- a. A 14x17in (35x43cm) tethered cassette sized panel
- b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection
- c. A 17x17in (43x43cm) tethered panel for fixed installations.
6. Indication for use
The ClearVision ExamVue Flat Panel Detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
The ClearVision ExamVue Flat Panel Detector is not indicated for use in mammography.
7. Comparison with Predicate Device:
JPI Healthcare Co., Ltd, believes that the ClearVision ExamVue Flat Panel Detector is substantially equivalent to the ATAL-8 detector of Atlaim and the LTX240AA01-A of Samsung Mobile Display, Ltd.
The ClearVision ExamVue Flat Panel Detectors have similar or superior characteristics to the predicate devices, including:
- The same aSi TFTD technology, converting visible light from a a. scintillator into a digital image.
- b. Similar pixel pitch (140um-143um for the Clear Vision Exam Vue Flat
5
Panels vs 139um-143um for the predicate devices)
- Exclusively CsI scintillators, compared to the option of CsI or the lower C. performance Gadolinium Oxide scintillator in the predicate devices.
- d. Similar indications for use, focused on general radiography and excluding mammography.
- Have been integrated to function with the same image acquisition e. software, ExamVueDR, for final processing and presentation.
Clinical images were provided; these images were not necessary to establish equivlance based on the modifications to the device (x-ray detector technology identical to predicate devices) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.
The image acquisition control interface testing was performed as part of laboratory and clinical testing. This control interface consists of hard wired control signal to the x-rav generator (all models) or AED (FDX3543RPW). The software control interface for exposure settings on selected generators had been previously tested in the notification of the ExamVueDR software as a stand-alone product (K142930).
-
- Safety, EMC and Performance Data
Bench tests reports have been provided, detailing the safety and EMC testing, as well as non-clinical performance data for the ClearVision ExamVue Flat Panel Detector.
- Safety, EMC and Performance Data
Biocompatibility data has been provided for patient-contacting surfaces of the device, demonstrating that there are no known adverse reactions to skin contact with the device.
We have also provided clinical testing of the hardware, showing comparison images using identical software, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"
-
- Conclusions:
In accordance with the Federal Food. Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that The ClearVision ExamVue Flat Panel Detector is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart.
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EXHIBIT 1
SUBSTANTIAL EQUIVALENCE CHART
| Device Name | ExamVue
FPD
FDX3543RP | Examvue FPD
FDX3543RPW | Examvue
FPD
FDX4343R | ATAL-8 | LTX240AA01-
A |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Toshiba | Toshiba | Toshiba | ATLAIM | Samsung
Mobile Display |
| FDA 510(k)
K# | K160143 | K160143 | K160143 | K113812 | K090742 |
| Intended use. | The ClearVision ExamVue Flat Panel detector
is indicated for use in general radiology,
specialist radiology including podiatry,
orthopedic, and other specialties, and in mobile
x-ray systems.
The ClearVision ExamVue Flat Panel detector
is not indicated for use in mammography. | The ClearVision ExamVue Flat Panel detector
is indicated for use in general radiology,
specialist radiology including podiatry,
orthopedic, and other specialties, and in mobile
x-ray systems.
The ClearVision ExamVue Flat Panel detector
is not indicated for use in mammography. | The ClearVision ExamVue Flat Panel detector
is indicated for use in general radiology,
specialist radiology including podiatry,
orthopedic, and other specialties, and in mobile
x-ray systems.
The ClearVision ExamVue Flat Panel detector
is not indicated for use in mammography. | The ATAL 8
and ATAL 8C
are indicated
for use in
general
radiographic
images of
human
anatomy. It is
intended to
replace
radiographic
film/screen
systems in all
general-
purpose
diagnostic
procedures,
excluding
fluoroscopic,
angiographic,
and
mammographic
applications. | LTX240AA01-
A digital flat
panel X-ray
detector is
indicated for
digital imaging
solution
designed for
providing
general
radiographic
diagnosis of
human
anatomy
targeting both
adult and
children. It is
intended to
replace film
based
radiographic
diagnostic
systems and
provide a case
diagnosis and
treatment
palnning for
physicians and
other health
care
professionals.
Not to be used
for
mammography. |
| Configuration | | This submission is for the digital panel and | | This | This |
7
| | software only, no generator or stand provided. | | | submission is
for the digital
panel only, no
generator or
stand provided. | submission is
for the digital
panel only, no
generator or
stand provided. |
|-----------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Detector Type | Amorphous Silicon (a-Si) Photodiode | | | SAME | SAME |
| Pixel Pitch | 143um | 140um | 143um | 139um | 143um |
| Limiting
Resolution | 3.7lp/mm | 3.7lp/mm | 3.7lp/mm | Over 3lp/mm | 3lp/mm |
| A/D
Conversion | 16 bit | 14 bit | 14 bit | 14 bit | 14 bit |
| Active Area | 14x17 inch | 14x17 inch | 16.9x17.3 inch | 17x17 inch | 17x17 inch |
| Dimensions
(mm) | 384(w) x
460(D) x
15(H) | 384(w) x
460(d) x 15(h) | 512(w) x
495(d) x
43(h) | 500(w) x
500(1) x 25(h) | 500(w) x
497(1) x 44mm
(H) |
| Weight | 3kg | 3kg | 9kg | 7.8kg | 13.4kg |
| Pixels | 2448x2984
(7.3Mpx) | 2466x3040
(7.5Mpx) | 3008x3072
(9.2Mpx) | 3072x3072
(9.4Mpx) | 3072x3072
(9.4Mpx) |
| DQE @ 1
lp/mm | 57% | 60% | 58% | 33% Gadox /
46% CsI | 45% Gadox /
65% CsI |
| MTF @ 1
lp/mm | 63% | 68% | 65% | 63% Gadox /
72% CsI | 57% Gadox /
59% CsI |
| DICOM | Yes | Yes | Yes | Yes | Yes |
| Scintillator | CsI | CsI | CsI | CsI/Gadox | CsI/Gadox |
| Interface | Gigabit
Ethernet | Gigabit
Ethernet or
Wireless | Gigabit
Ethernet | Gigabit
Ethernet | Gigabit
Ethernet |
| Automatic
Exposure
Detection | No | Yes | No | Yes | No |
| Generator
Exposure
Trigger or
Sensor | Yes | Yes | Yes | Yes | Yes |
| Power Source | AC Line | AC Line | AC Line | AC Line | AC Line |
| Standards | Electrical
Safety per
IEC 60601-1
and EMC per
IEC 60601-
1-2. | Electrical
Safety per IEC
60601-1 and
EMC per IEC
60601-1-2. | Electrical
Safety per
IEC 60601-1
and EMC per
IEC 60601-
1-2. | Electrical
Safety per IEC
60601-1 and
EMC per IEC
60601-1-2. | Electrical
Safety per IEC
60601-1 and
EMC per IEC
60601-1-2. |
| Acquisition
and Control
Software | Exclusively
ExamVueDR
(K142930) | Exclusively
ExamVueDR
(K142930) | Exclusively
ExamVueDR
(K142930) | *Option for
ExamVueDR
(K142930) | *Option for
ExamVueDR
(K142930) |
8
*: The ExamVueDR software 510(k) notification (K149230) includes the indicated detector as one of the detectors the software can be integrated with to form a retrofit solution. The ExamVueDR software is not referenced in the 510(k) notification for the detector itself.
The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. The image acquisition and user interface software in the device has been previously 510(k) notified for use with the predicate devices. For this reason, we believe it is substantially equivalent to the predicate devices.