(107 days)
Not Found
No
The document describes standard digital image processing techniques (filtering, gain/offset correction, flat fielding) and does not mention AI, ML, or related concepts like neural networks or deep learning.
No
This device is a Computed Radiography System that produces digital X-ray images for diagnostic purposes, it does not provide any therapeutic function.
Yes
The device produces X-ray diagnostic images, and its intended use is to produce "digital X-Ray images for general radiography purposes", which are used for diagnosis. The device description also states it "produces the X-ray diagnostic image in digital format".
No
The device description explicitly states it comprises a scanner, cassette with reusable phosphor storage plate (IP), and workstation software. This includes significant hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "producing digital X-Ray images for general radiography purposes." This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details the process of capturing X-ray images using a phosphor plate and converting them into digital format for viewing and processing. This is a standard medical imaging workflow.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological specimens.
The device is a medical imaging system used for diagnostic purposes in vivo (within the body) through the use of X-rays.
N/A
Intended Use / Indications for Use
This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff.
This device is not intended for the acquisition of mammographic image data.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The FireCR Spark is Computed Radiography System which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate. X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiological environment by qualified staff.
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 & Clinical considerations according to FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
In clinical considerations, The rating was considered equivalent by radiologists.
As a result of Clinical Study, FireCR Spark is considered that Image quality is equivalent to the Predicate Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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510(k) Summary K133106
This 510(k) summary information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date prepared: December 12, 2013
JAN 1 5 2014
-
Company and Correspondent making the submission: Name - 3D Imaging & Simulations Corp. Address - 815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea Telephone - +82-42-931-2100 Fax - +82-42-931-2299 Contact - Jiin Jung / Vice President E-mail - jiinjung@3-disc.com
-
Device :
| Trade/proprietary name: | FireCR Spark |
|---|---|
| Common Name: | Computed Radiography Scanner |
| Classification Name: | Stationary x-ray system |
-
- Predicate Device :
| Manufacturer: | 3D Imaging & Simulations Corp. |
|---|---|
| Device: | FireCR |
| 510(k) Number: | K102619 (Decision Date – Mar. 1. 2011) |
4. Classifications Names & Citations :
21CFR 892.1680, MQB - Stationary x-ray system, Class 2
5. Description :
5.1 General
The FireCR Spark is Computed Radiography System which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate. X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
5.2 Main Features
Modern Scanning Mechanism
FireCR Spark adopts an updated scanning mechanism constructed in a compact and rigid structure. High Throughput: Its unique scanning mechanism enables to improve the efficiency and high throughput.
Scanning Resolution: User selectable resolution of 100um allows user to make diagnosis on variable purposes.
Detector
High sensitivity photomultiplier tube supplied in the FireCR Spark delivers high gain, wide dynamic range and high speed response for radiographic imaging.
Acquisition and Diagnostic Software: QuantorMed Plus Acquisition and Diagnostic Software's accurate and rapid data processing make the scanner powerful.
5.3 Product features
-
Photomultiplier Tube (PMT)
-
35cm x 43cm, 24cm x 30cm, 18cm x 24cm imaging area.
-
Wide dynamic range with 16-bit digitization
1
- Image process parameters are selectable according to the body part to make best images for diagnosis
- DICOM3.0 standard compliance
- User Selectable Scanning Resolution : 100µm and 200µm
-
- Indications for use :
This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data.
7. Comparison with predicate device :
3D Imaging & Simulations Corp. believes that the FireCR Spark is substantially equivalent to FireCR.
| | | FireCR
3D Imaging & Simulations Corp. | FireCR Spark
3D Imaging & Simulations Corp. |
|-----------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K102619 | K133106 |
| Intended Use | | The FireCR imaging system is
indicated for capturing, digitization
and processing of general
radiography images stored in
imaging plate recording media. | The FireCR Spark imaging system is
indicated for capturing, digitization and
processing of general radiography
images stored in imaging plate
recording media. |
| Physical
Characteristics | Overall
Dimensions | Reader
464 x 703 x 117mm | Reader
445 x 795 x 80 mm |
| | Imaging Area | 14" x 17" (35cm x 43cm)
10" x 12" (25cm x 30cm) | 35cm x 43cm SAME
24cm x 30cm (SLIGHT
DIFFERENCE)
18cm x 24cm (NEW SIZE) |
| | Effective Pixel
Pitch | 100μm, 200μm | 100μm, 200μm |
| | Spatial
Resolution | 3.71p/mm @ 100μm | 3.7lp/mm @ 100μm |
| | Image Matrix
(Pixel) | 35cm x 43cm
3500 x 4300 @ 100μm
1750 x 2150 @ 200μm
25cm x 30cm
2500 x 3000 @ 100μm
1250 x 1500 @ 200μm | 35cm x 43cm SAME:
3500 x 4300 @ 100μm SAME
1750 x 2150 @ 200μm SAME
24cm x 30cm (SLIGHT
DIFFERENCE):
2400x3000 @ 100μm (SLIGHT
DIFFERENCE)
1200 x 1500 @ 200μm (SLIGHT
DIFFERENCE)
18cm x 24cm (NEW SIZE):
1800 x 2400 @ 100μm
900 x 1200@ 200μm |
| | Weight | 30kg | 19.5kg |
| | Imaging Device | High Sensitivity Photo Multiplier
Tube (s-PMT) | High Sensitivity Photo Multiplier Tube
(s-PMT) |
2
| | | FireCR
3D Imaging & Simulations Corp. | FireCR Spark
3D Imaging & Simulations Corp. |
|--------------------------------|------------------------|----------------------------------------------------------|----------------------------------------------------------|
| Photo | | | |
| Operational
Characteristics | Operating
Condition | Temperature : 0-40°C
Humidity: 15%-95% RH | Temperature : 0-40°C
Humidity: 15%-95% RH |
| | Power
Requirements | 100-250VAC +/- 10%,
50/60Hz | 100-250VAC +/- 10%,
50/60Hz |
| | Methods of
Exposure | Register Patient →
X-ray Exposure | Register Patient >
X-ray Exposure |
| | X-ray Absorber | Imaging plate | Imaging plate |
| Functional
Characteristics | Output Data | Dicom3.0 Compatible | Dicom3.0 Compatible |
| | DQE | 23.5% @ 0.5 lp/mm | 25% @ 0.5 lp/mm |
| | MTF | 79% @ 0.5 Ip/mm | 80% @ 0.5 lp/mm |
| | Defect
Compensation | By Calibration | By Calibration |
| | Dynamic Range | 16bit | 16 bit |
| | Image
Processing | Image processing parameter is
selectable by body part | Image processing parameter is
selectable by body part |
| DICOM Compatibility | | DICOM 3.0 Compliant | DICOM 3.0 Compliant |
| Standards | | IEC 60601-1; IEC 60601-1-2
IEC 62220-1 | SAME |
The FireCR Spark's imaging principle, physical characteristics, target population and intended use are the same as those of FireCR. However, the differences in the design are follows:
- The technical specification (including DQE, MTF), mechanical structure and physical appearance of the FireCR Spark is a little different from the FireCR. - The testing of the FireCR Spark demonstrates that the performance is substantially equivalent to the predicate devices cited above.
In clinical considerations, - The rating was considered equivalent by radiologists.
- As a result of Clinical Study, FireCR Spark is considered that Image quality is equivalent to the Predicate Device.
Summary of comparison:
The Fire Spark described in this 510(k) has the same intended use and similar technical characteristics to the FireCR. The similarities and differences between these systems are described in the table shown above.
The similarities are as follows:
Intended use with FireCR; Capturing image, Image Processing, and DICOM compatible features with FireCR X-ray exposing technique with FireCR; Effective Pixel Pitch with FireCR; Spatial resolution with FireCR; X-ray absorber material with FireCR; Image making process with FireCR; Energy Sources, Source to skin distance with FireCR; Workstation and operating system with FireCR
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R133106
Page 4 of 4
Differences are as follows:
(1) Difference in Mechanical Structure and Physical Appearance (Now the structure is more modular) Mechanical structure and physical appearance of FireCR Spark is different from those of FireCR. (2) Difference in DQE and MTF: FireCR Spark shows slightly better DQE and MTF compared to the FireCR. This is due to the uses of a multi layer fiber bundle.
Laser scanning to
Image /page/3/Figure/3 description: The image shows two diagrams comparing single-layer and multi-layer fiber bundles used in fluorescence imaging. The first diagram illustrates a single-layer fiber bundle collecting fluorescence signals from an imaging plate stimulated by laser scanning. The second diagram shows a multi-layer fiber bundle collecting fluorescence signals from an imaging plate also stimulated by laser scanning. The diagrams highlight the difference in fiber bundle arrangement and their respective roles in collecting fluorescence signals.
(3) A new panel size is now available, allowing the user greater imaging flexibility (see table above). In summary, The FireCR Spark does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
8. Safety, EMC, Biocompatibility and Performance Data :
Electrical, mechanical, environmental safety and performance testing to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Non-clinical & Clinical considerations according to FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
9. 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 3D Imaging & Simulations Corp. concludes that the Computed Radiography Reader System (FireCR Spark) is safe and effective and substantially equivalent to predicate device as described herein. These modifications pose no risk to safety and effectiveness because they enhance reliability (modular construction) and they provide slightly better performance characteristics (multi layer fiber bundle) rendering the modifications substantially equivalent to our predicate device. There is also an added imaging plate size which gives the user a greater choice in their imaging needs (18cm x 24cm NEW SIZE, 1800 x 2400 @ 100um and 900 x 1200@ 200um.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or flowing elements. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2014
3DISC Americas % Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K133106
Trade/Device Name: Fire CR Spark Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: December 12, 2013 Received: December 16, 2013
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 or any I coonal statues and 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 device-related adverse ovenas) (21 OFF Part 820); and if applicable, the electronic fordination control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Kamım
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/7 description: The image shows a logo with the letters "FDA" in a stylized, geometric font. The letters are interconnected and have a maze-like appearance due to the use of parallel lines. There is a signature-like flourish that overlays the letters, adding a personal touch to the design.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K133106
Device Name: Computed Radiography Scanner / FireCR Spark
Indications for Use:
This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff.
This device is not intended for the acquisition of mammographic image data.
Prescription Use X_
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________
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