(120 days)
Not Found
No
The summary describes a standard digital X-ray detector and explicitly states that it does not include an image processing unit (console). There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
Yes.
Explanation: The "Intended Use" section states the device is "intended to capture for display radiographic images of human anatomy." The "Device Description" also clarifies that the device "transfer[s] for radiography diagnostic." This indicates that the device captures images that are then used for diagnostic purposes.
No
The device description explicitly states it is a "portable digital detector" and a "Flat Panel Detector," which are hardware components used to acquire and digitize X-ray exposures. While it integrates with software (operating PC), the core device itself is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The INNOLUX RIC Flat Panel Detector is an X-ray imaging device. Its purpose is to capture radiographic images of human anatomy using X-rays. This is an in vivo process (performed within the living body).
- Intended Use: The intended use clearly states it's for capturing radiographic images for display, not for performing tests on biological samples.
- Device Description: The description details its function in acquiring and digitizing X-ray exposures, not analyzing biological samples.
The device is a medical imaging device, specifically a digital X-ray detector, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Wireless/Wired INNOLUX RIC flat panel detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX RIC is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Product codes
MQB
Device Description
The INNOLUX RIC Flat Panel Detector is a portable digital detector that integrated with an operating PC and an X-ray generator to acquire and digitize x-ray exposures from, standard radiographic systems and transfer for radiography diagnostic. The INNOLUX RIC is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired data communication. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.
Mentions image processing
"In order to display an image, it requires the image processing unit to meet the interface specification of RICMC."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy
Indicated Patient Age Range
Pediatric and neonatal exams, adults
Intended User / Care Setting
General projection radiographic applications wherever conventional film/screen or CR systems may be used.
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 Performance Data: INNOLUX RIC conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (issued on August 6, 1999) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (issued August 14, 2013) was followed to test. As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory. Furthermore, the image quality evaluation confirmed that the image quality of the INNOLUX RIC detectors is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE (RQA5, 1 Ip/mm, 1mR) – detector alone, without tabletop:
RIC 35G,RIC 43G: 31% Measurement tolerance (±10%)
RIC 35C,RIC 43C: 54% (Csl) Measurement tolerance (±10%)
MTF (RQA5, 2 lp/mm):
RIC 35G,RIC 43G: 42% Measurement tolerance (±10%)
RIC 35C,RIC 43C: 54% Measurement tolerance (±10%)
Predicate Device(s)
Reference Device(s)
Not Found
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2016
INNOLUX Corporation % Mr. Andy Kuo Director No. 3, Sec. 1, Huansi Rd. Tainan City, Southern Taiwan Science Park, 74147 TAIWAN (R.O.C.)
Re: K162344 Trade/Device Name: INNOLUX RIC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 23, 2016 Received: November 29, 2016
Dear Mr. Kuo:
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/ResourcesforYou/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 Ochs
Robert Ochs, Ph.D. 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)
Device Name
INNOLUX RIC
Indications for Use (Describe)
The Wireless/Wired INNOLUX RIC flat panel detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX RIC is not intended for mammography, fluoroscopy, tomography, and angiography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
INNOLUX RIC
Date: November 23, 2016
Submitter's Information:
INNOLUX Corporation No.3, Sec. 1, Huansi Rd., Tainan City, Southern Taiwan Science Park, 74147, Taiwan (R.O.C.)
Contact Person:
| Name: | Andy Kuo |
|---|---|
| Title: | Director |
| Telephone: | +886-37-586000 #64330 |
| Facsimile: | +886-37-586000 #65992 |
Identification of the Device:
Proprietary/Trade Name: INNOLUX RIC Classification Name: Stationary x-ray system 21 CFR 892.1680 Regulations Number: Product Codes: MQB Device Class: Class II Review Panel: Radiology Common Name: Flat Panel Digital Detector System
Identification of the Legally Marketed Device:
FDR D-EVO II Flat Panel Detector System. K142003 cleared 10/21/2014 VIVIX-S WIRELESS, K122865 cleared 02/01/2013
l. DEVICE DESCRIPTION
The INNOLUX RIC Flat Panel Detector is a portable digital detector that integrated with an operating PC and an X-ray generator to acquire and digitize x-ray exposures from, standard radiographic systems and transfer for radiography diagnostic. The INNOLUX RIC is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired data communication. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.
II. INDICATIONS FOR USE
The Wireless/Wired INNOLUX RIC flat panel detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The INNOLUX RIC is not intended for mammography, fluoroscopy, tomography, and angiography applications.
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SUBSTANTIAL EQUIVALENCE lll.
INNOLUX RIC is substantially equivalent to the following legally marketed device.
| Legally Marketed Device | 510(k) # | Clearance Date |
|---|---|---|
| VIVIX-S WIRELESS | K122865 | 02/01/2013 |
| FDR D-EVO II Flat Panel Detector System | K142003 | 10/21/2014 |
INNOLUX RIC and FDR D-EVOII / VIVIX-S WIRELESS are portable digital detector systems that are used to acquire x-ray exposures. The INNOLUX RIC has the same Indications for Use, and very similar functional and technical requirements as the currently-cleared predicate device, K122865 / K142003. The most detector characteristics remain unchanged for INNOLUX RIC, and the image quality is substantially equivalent to the predicate device. The design made for the INNOLUX RIC have been successfully tested and validated as summarized below.
Predicate Comparison Table:
| | Subject/Proposed Device | Predicate Device K142003,
DR-ID1201SE, DR-ID1202SE
DR-ID1211SE, DR-ID1212SE |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | RIC 35G,RIC 43G
RIC 35C,RIC 43C
The Wireless/Wired INNOLUX RIC flat panel
detector is intended to capture for display
radiographic images of human anatomy. It is
intended for use in general projection radiographic
applications including pediatric and neonatal
exams wherever conventional film/screen or CR
systems may be used. The INNOLUX RIC is not
intended for mammography, fluoroscopy,
tomography, and angiography applications. | The Wireless/Wired FDR D-EVO II flat panel
detector system is intended to capture for display
radiographic images of human anatomy. It is
intended for use in general projection radiographic
applications including pediatric and neonatal
exams wherever conventional film/screen or CR
systems may be used. The FDR D-EVO II is not
intended for mammography, fluoroscopy,
tomography, and angiography applications. |
| Scintillator | Same as K142003
RIC 35G, RIC 43G Gd2O2S:Tb
RIC 35C, RIC 43C CsI:Tl | DR-ID1201SE, DR-ID1202SE Gd2O2S:Tb
DR-ID1211SE, DR-ID1212SE CsI:Tl |
| X-ray
Conversion | Same as K142003 | Indirect conversion (a-Si) |
| Detector Cord | Same as K142003 | Wired / Wireless |
| Detector Weight | RIC 35G, RIC 35C:Approx. 6.5 lbs
RIC 43G, RIC 43C:Approx. 8.0 lbs | DR-ID1201SE,DR-ID1211SE : Approx.5.8 lbs
DR-ID1202SE,DR-ID1212SE : Approx.7.1 lbs |
| Exposure
size/Active Area
(inch) | Same as K142003
RIC 35G, RIC 35C:13.8x16.8
RIC 43G ,RIC 43C:16.8x16.7 | DR-ID1201SE, DR-ID1211SE :13.8x16.8
DR-ID1202SE, DR-ID1212SE :16.8x16.7 |
| Dimensions
(inch)
(Detector
exterior) | Same as K142003
RIC 35G, RIC 35C:
18.1(W) x 15.1(D) x 0.6 (H)
RIC 43G, RIC 43C:
18.1(W) x 18.1(D) x 0.6 (H) | DR-ID1201SE, DR-ID1211SE:
18.1(W) x 15.1(D) x 0.6 (H)
DR-ID1202SE, DR-ID1212SE:
18.1(W) x 18.1(D) x 0.6 (H) |
| Pixel Size | Same as K142003 | 150 μm |
| Acquisition Bit
Depth | Same as K142003 | 16 bit |
| DQE (RQA5, 1
Ip/mm, 1mR) –
detector alone,
without
tabletop | RIC 35G,RIC 43G
31%
Measurement tolerance (±10%)
RIC 35C,RIC 43C
54% (Csl)
Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE
30%
Measurement tolerance (±10%)
DR-ID1211SE,DR-ID1212SE
54% (Csl)
Measurement tolerance (±10%) |
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Image /page/5/Picture/0 description: The image shows the logo for Innolux. The logo is in blue, red, and green. Below the English name is the Chinese name for the company in black.
| Subject/Proposed Device | Predicate Device K142003, | |
|---|---|---|
| RIC 35G,RIC 43G | DR-ID1201SE,DR-ID1202SE | |
| RIC 35C,RIC 43C | DR-ID1211SE,DR-ID1212SE | |
| MTF (RQA5, 2 | ||
| lp/mm) | RIC 35G,RIC 43G | |
| 42% | ||
| Measurement tolerance (±10%) | DR-ID1201SE,DR-ID1202SE | |
| 42%(High mode) | ||
| Measurement tolerance (±10%) | ||
| RIC 35C,RIC 43C | ||
| 54% | ||
| Measurement tolerance (±10%) | DR-ID1211SE,DR-ID1212SE | |
| 54%(High mode) | ||
| Measurement tolerance (±10%) | ||
| *Standard | ||
| Configuration | ||
| Components | System requires | |
| one or more RIC detectors, one or two power | ||
| supply unit(s), and one control unit*. | System requires | |
| one FDX Console, one or more D-EVO detectors, | ||
| one or two power supply unit(s), | ||
| and one control unit*. | ||
| * In order to display an image, it requires the | ||
| image processing unit to meet the interface | ||
| specification of RICMC. | *Depending on configuration, the control unit | |
| software can be installed in the FDX Console | ||
| PC. | ||
| *Workstation | N/A | |
| Workstation is not included in the system. | ||
| Same as K122865 | FDX Console Version 8.0 and above |
*The Subject device and another predicate. K122865 are not including image processing unit (console).
IV. SUMMARY OF STUDIES
Non-clinical Performance Data: INNOLUX RIC conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (issued on August 6, 1999) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (issued August 14, 2013) was followed to test. As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory. Furthermore, the image quality evaluation confirmed that the image quality of the INNOLUX RIC detectors is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
V. CONCLUSION
Based upon the supporting data summarized above, we concluded the INNOLUX RIC is as safe and effective as the legally marketed device FDR D-EVO II (K142003) and VIVI-S WIRELESS (K122865), and do not raise different questions of safety and effectiveness than K132509 and K122865.