← Product Code [MQB](/productcode/MQB) · K052661 # QUIX DIGITAL RADIOGRAPHIC UPGRADE (K052661) _Edge Medical Devices , Ltd. · MQB · Jun 7, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K052661 ## Device Facts - **Applicant:** Edge Medical Devices , Ltd. - **Product Code:** [MQB](/productcode/MQB.md) - **Decision Date:** Jun 7, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography. ## Device Story Quix Digital Radiography Upgrade converts conventional film-screen X-ray systems to digital radiography. System replaces film-screen and bucky with digital bucky and operator console. Digital bucky utilizes selenium-based flat panel detector (16" x 17" area) to capture X-ray images. Plasma DR readout technology uses moving line scanner to sweep sensor surface, reading out latent charge image. Operator console provides local image storage; communicates via DICOM 3.0. Used in clinical settings by radiology staff. Output displayed in ~10 seconds; provides diagnostic images for general radiography. Benefits include digital image processing (optimized gray scale) and faster workflow compared to analog film-screen systems. ## Clinical Evidence Bench testing only. No clinical data provided. Performance characteristics compared to predicates include spatial resolution (0.7 @ 1lp/mm, 0.35 @ 2lp/mm, 0.1 @ 3lp/mm), dynamic range (12 bits), and image processing time (~10 seconds). ## Technological Characteristics Amorphous selenium X-ray converter; 16" x 17" monolithic flat panel detector; 2540 x 2700 pixel array; 160 µm pixel size; 12-bit dynamic range. Moving line scanner readout. DICOM 3.0 connectivity. Digital image processing for gray scale optimization. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - AGFA CP-B 200 screen / AGFA CP-BU New film (exempt from 510(k)) - Fuji CR 5501D ([K993861](/device/K993861.md)) - Infimed Stingray DR System ([K992794](/device/K992794.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K052661 JUN - 7 2006 ## Section 10 Administrative Requirements ## 510(k) Summary of Safety and Effectiveness 1. Submitter : EDGE MEDICAL DEVICES Ltd. 25 Hatasia St. P.O. Box 2126 Raanana 43654 lsrael Contact: Vered Scharf vscharf@edge-medical.com Eli Shalev eshalev@edge-medical.com 972-9-7413675 September, 2005 - 2. Device Name: | Classification Name: | Solid State X-ray Imaging Device | |----------------------|----------------------------------| | Common/Usual Name | Flat Panel Digital Imager | | Proprietary Name | Quix Digital Radiography Upgrade | - 3. Equivalent Devices: | Proprietary
Name: | AGFA CP-B 200
screen / AGFA CP-BU
New film | Fuji CR 5501D | Infimed Stingray DR
System | |--------------------------|--------------------------------------------------|--------------------------------|-------------------------------| | 510(k) Numbers: | exempt from 510(k) | K993861 | K992794 | | Common Name: | Analog Screen-Film
system | Computed Radiography
System | Digital Radiography
System | | Regulatory Class: | Class I (screen and film) | Class II | Class II | | Classification
Panel: | Radiology | Radiology | Radiology | | Product Code: | 892.1960 (screen)
892.1840 (film) | 901XW 892.1900 | 90MQB 892.1650 | ## 4. Device Description: The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range September, 2005 510(k) Premarket Notification Submission {1}------------------------------------------------ of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols. - క్. Statement of Intended Use: The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography. Comparison to substantially equivalent devices: റ. AGFA CP-B 200 screen / AGFA CP-BU New film Fuji Computed Radiography System K893861 Infimed Stingray Digital Radiography System K992774 The following chart depicts the comparison characteristics. | Item | Current Device | Predicate Device | Predicate Device | Predicate Device | |---------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Device | Quix DR Upgrade | AGFA CP-B 200 screen / AGFA CP-BU New film | Fuji CR System | Infimed Stingray DR Upgrade | | 510(k) Number | | exempt from 510(k) | K993861 | K992794 | | Intended Use | Provide diagnostic images for general radiographic use | Same | Same | Same | | Anatomical Sites | General radiography | Same | Same | Same | | Target Population | General population | Same | Same | Same | | Design | Digital acquisition, electronic processing | Analog acquisition, chemical processing | Digital acquisition, electronic processing | Digital acquisition, electronic processing | | X-ray Converter | Amorphous selenium, converts X-rays to latent charge image | Fluorescent screen, converts X-rays to light | Photostimulable phosphor imaging plate converts X-rays to stable exited states of the material | Cesium lodide scintillator, converts X-rays to light | | Image Readout | Plasma DR Readout Technology – line scanner sweeps across sensor surface to readout latent charge image. | Silver halide film | Mechanical scanner sweeps Laser across phosphor surface to readout latent stored image. | Photodiode and TFT amorphous silicon active matrix array convert light to electrical charge which is readout electronically. | | Moving line scanner | Yes | No | Yes | No | | Performance | Digital image processing (optimized gray scale) | Chemical processing (fixed gray scale) | Digital image processing (optimized gray scale) | Digital image processing (optimized gray scale) | | Imaging area | 16" x 17" | 14" x 17" | 14" x 17" | 17" x 17" | | Monolithic sensor | Yes | Yes | Yes | No (tiled subarrays) | | Pixel array size | 2540 x 2700 | N/A | 2140 x 2140 | 2981 x 3021 (from 510(k))
3000 x 3000 (current "chart smart") | September, 2005 510(k) Premarket Notification Submission {2}------------------------------------------------ | Item | Current Device | Predicate Device | Predicate Device | Predicate Device | |-----------------------|-----------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Device | Quix DR Upgrade | AGFA CP-B 200 screen/ AGFA CP-BU New film | Fuji CR System | Intimed Stingray DR Upgrade | | Pixel size | $160 \mu m$ | $<100 \mu m$ | 200 $\mu m$ in standard mode
100 $\mu m$ in high density mode | $143 \mu m$ | | Dynamic Range | 12 bits (4,096) | Approximately x50 | 10 bits (1,024) | 14 bits (16,384) | | Connectivity | DICOM 3.0 Compatible | N/A | DICOM 3.0 Compatible | DICOM 3.0 Compatible | | Image processing time | 10 sec | 90 sec | 3-5 minutes per image | 30 sec (from 510(k))
<8 sec (current "chart smart") | | Spatial resolution | 0.7 @ 1lp/mm
0.35 @ 2lp/mm
0.1 @ 3lp/mm | N/A | Standard mode:
0.65 @ 1lp/mm
0.3 @ 2lp/mm
0.1 @ 3lp/mm
High density mode:
0.8 @ 1lp/mm
0.5 @ 2lp/mm
0.3 @ 3lp/mm | 0.7 @ 1lp/mm
0.35 @ 2lp/mm
0.15 @ 3lp/mm | : 10-3 510(k) Premarket Notification Submission {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 JUN -7 2006 Vered Scharf, Ph.D. R&D Manager EDGE Medical Devices Ltd. 25 Hatasiya P.O. Box 2126 Raanana Ind. Zone, 43654 ISRAEL Re: K052661 Trade/Device Name: Quix Digital Radiography Upgrade Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: April 20, 2006 Received: May 2, 2006 Dear Dr. Scharf: 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below this text is a large, bold "FDA" and the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a dotted circle. Protecting and Promoting Public Health {4}------------------------------------------------ Page 2 - 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |----------------|---------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C Hodgdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indication for Use Statement 510(k) Number (if known): K 05 266 ا Quix Digital Radiography Upgrade Device Name: _ Indications for Use: The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intented for use The Quix Digital Radiography Opplications wherever conventional firm-screen systems may in general radiographic examinations and applications wherever conventional film-scree in general radiographic examinations and applications with the many ography. be used, excluding mammography, fluoroscopy, and angiography. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Brogdon Division Sign-Off and Ra 510(k) Num Prescription Use September, 2005 V 510{k} Premarket Notification Submission 40-5 --- **Source:** [https://fda.innolitics.com/device/K052661](https://fda.innolitics.com/device/K052661) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com