← Product Code [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR) · K080614 # DR VISION NEO, DR VISION DOU (K080614) _Almana Medical Imaging · KPR · Jun 20, 2008 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K080614 ## Device Facts - **Applicant:** Almana Medical Imaging - **Product Code:** [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR.md) - **Decision Date:** Jun 20, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Intended Use These are Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The systems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions. ## Device Story DR Vision Neo and DR Vision Duo are stationary digital diagnostic X-ray systems utilizing Trixell Pixium 4600 flat panel detectors. Systems capture X-ray exposures, converting them into digital images without conventional film/screen. Neo model features single panel; Duo model features two panels (wall stand and patient table). Includes ceiling-suspended tube stand with auto-tracking and battery-operated mobile elevating table with 4-way floating top. Operated by clinicians in clinical settings. Images are transmitted electronically to remote workstations, archives, and printers. Digital acquisition improves workflow efficiency and diagnostic image quality. Benefits include instant image availability and reduced patient positioning time. ## Clinical Evidence Bench testing and laboratory testing were performed to verify performance standards (21 CFR 1020.30) and electrical safety (IEC-60601). No clinical data was required or presented to establish substantial equivalence. ## Technological Characteristics Stationary X-ray system; Amorphous silicon flat panel detector with cesium iodide scintillator; 143 x 143 micron pixels; 3121 x 3121 matrix; 14-bit data conversion; 16,000 grayscales; 32-80 kW power range; Ceiling-suspended tube stand; Motorized auto-tracking; Connectivity via IHE/HL-7/DICOM standards; Electrical safety per IEC-60601. ## 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 - Siemens Axiom Aristos FX Plus Digital Radiography System ([K061054](/device/K061054.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}------------------------------------------------ K080614 pg. 1 of 2 ### 510(k) Summary 510(k) Number K08 Almana Medical Imaging P.O. Box 3568 Alkhobar 31952 Kingdom of Saudi Arabia T: +966 3 8679400 F: +966 3 8962421 Date Prepared: February 11, 2007 Mohammed Irfanullah Farooqui, Contact: Sales and Marketing Manager JUN 2 0 2008 - 1. Identification of the Device: Proprietary-Trade Name: DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems Classification Name: Stationary x-ray system, Product Codes 90 KPR and MQB Common/Usual Name: Stationary Diagnostic X-Ray - 2. Equivalent legally marketed device: K061054 Siemens Axiom Aristos FX Plus Digital Radiography System (uses identical digital panel). - 3. Indications for Use (intended use) Thesc arc Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The systems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions .. - 4. Description of the Device: DR Vision Neo is flat panel state-of-art digital imaging suite, driving significant improvements in productivity and quality. The streamlined efficiency of the DR Vision Neo enhance the entire radiographic operation, improving workflow by delivering diagnostic images instantly, and allowing users to move x-ray images clectronically to remote workstations, image archives, and printers. The DR Vision Neo is a Trixell Pixium 4600 flat panel detector based direct digital radiography system with ceiling suspended design. These are essentially standard diagnostic x-ray systems which have added to them a digital x-ray acquisition panel. The DR Vision Neo has a single panel while the DR Vision Duo has two panels, one in a wall stand and one in the patient table. Features are: * Flat panel detector: Amorphous silicon panel with cesium iodide scintillator offers exceptional DQE 17" x 17" size eliminates the need to rotate the panel for transverse views l 43 x 143 micron pixels in matrix of 3121 x 3121 x 14 bits. * High-precision 9 million pixel resolution. * 14-bit digital data conversion with 16.000 grayscales. * Motorized detector panel movements with auto-tracking with ceiling suspended tube stand. Battery operated mobile elevating table for radiological applications with 4-way floating table top allows easy and quick patient positioning. * IHE/HL-7/DICOM Standard - 5. Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a combination of alphanumeric characters and symbols. The first line reads "K0806/4", and the second line reads "Pg. 2 of 2". The text is written in a cursive style, and the overall impression is that of a page number or document identifier. | Characteristic | K061054 Siemens Axiom Aristos FX
Plus | DR Vision Neo and DR Vision Duo | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | A dedicated x-ray system with a flat
panel detector, which allows the
acquisition of x-ray exposures without
the use of conventional film/screen
systems. The AXIOM Aristos FX Plus
allows radiographic exposures of the
whole body including skull, spinal
column, chest, abdomen, extremities,
excluding mammography.
Radiographic exposures may be taken
with the patient in the sitting,
standing, or lying positions. | These are Radiographic X-Ray
Systems with a flat panel
detector(s), which allow the
acquisition of x-ray exposures
without the use of conventional
film/screen systems. The systems
allow radiographic exposures of the
whole body including skull, spinal
column, chest, abdomen,
extremities, excluding
mammography. Radiographic
exposures may be taken with the
patient in the sitting, standing, or
lying positions. | | Performance
Standard | 21 CFR 1020.30 | SAME | | Power range | 50 Kw or 80 Kw | 32-80 Kw | | Digital Panel | Trixell 4600 | Identical | | Electrical safety | Electrical Safety per IEC-60601. UL
listed | SAME | ## 6. Substantial Equivalence Chart #### 7. Conclusion After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Almana Medical Imaging that the DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 2 0 2008 Almana Medical Imaging % Mr. Daniel Kamm, P.E. Regulatory Engineer, Submission Correspondnet Kamm & Associates PO Box 7007 DEERFIELD IL 60015 Re: K080614 Trade/Device Name: DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 27, 2008 Received: May 30, 2008 ### 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 vour device in the Federal Register. {3}------------------------------------------------ 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K080614 Device Name: DR Vision Neo and DR Vision Duo Diagnostic X-Ray Systems Indications For Use: These are Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The svstems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions. Prescription Use X_ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Aoyui Mphy (Division Sign/C Division of Reproductive, Abdominal and Radiological Devices K080614 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Page 1 of 1 · --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K080614](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K080614) **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. 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