DigiX FDX

{0}------------------------------------------------ Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. Allengers Medical Systems Limited % Mr. Sanjeev K. Marjara Director Technical Bhankharpur, Mubarakpur Road Derabassi, Distt Mohali, Punjab 140507 INDIA Re: K192541 Trade/Device Name: DigiX FDX Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 10, 2019 Received: September 16, 2019 Dear Mr. Sanjeev Marjara: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for October 16, 2019 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K192541 Device Name DigiX FDX #### Indications for Use (Describe) The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatic patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/ supine position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes. | 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) | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. | | | <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | | | Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer | | of Chief Information Offic Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) SUMMARY K192541 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR 807.92 #### 1. Classification and Device Name | Device (trade) Name: DigiX FDX | | |----------------------------------|--| |----------------------------------|--| Common/usual Name: Digital X-Ray imaging system Classification Name: Stationary X-Ray system, Class II Classification: 21 CFR 892.1680 Classification Name: Stationary X-Ray System Classification Panel: Radiology > Device Class: Class II Device Code: KPR 510(K) Submission: Special #### 2. Contact Person and Address | Company Name: | Allengers Medical Systems Limited | |-----------------|--------------------------------------------------------------------------| | Address: | Bhankharpur, Mubarakpur<br>Road, Derabassi, Distt Mohali-140507<br>India | | Telephone No: | +91 1762-272600,<br>+91 9872980168 | | Contact Person: | Sanjeev K. Marjara | | Date Prepared: | 10 September 2019 | #### 3. Predicate Device: | Predicate Device: DigiX FDX | |-------------------------------------------------| | Classification: 21 CFR 892.1680 | | Classification Name: Stationary X-Ray system | | Common/usual Name: Digital X-Ray imaging system | | Device Class: Class II | | 510(K) Number: K162529 | | Product Code: KPR | {4}------------------------------------------------ - 4. Secondary Predicate Device: Secondary Device: Ysio | Classification: | 21 CFR 892.1680 | |----------------------|------------------------------| | Classification Name: | Stationary X-Ray system | | Common/usual Name: | Digital X-Ray imaging system | | Device Class: | Class II | | 510(K) Number: | K081722 | | Product Code: | KPR | Allengers supplies digital detectors that have been previously cleared by the FDA or tested and evaluated per Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices. Table 1 provides the list of solid state X-Ray image detectors used in device | Solid State X-Ray Image Detectors | 510(K) Numbers | |--------------------------------------------|----------------| | Varex PaxScan 4343R – Fixed | K130318 | | Varex PaxScan 4343R v3- Fixed | K183541 | | Thales Pixium RAD 4343 C-E (Fixed) | K181279 | | Varex Paxscan 4343CB - Fixed | K190373 | | IRAY VENU 1717X – Fixed | -- | | Varex PaxScan 4336R - Portable | K130318 | | Varex (Perkin Elmer ) XRPAD 4343F | K142698 | | Varex PaxScan 4336W - Wireless | K142049 | | Varex (Perkin Elmer) XRPAD 4336 – Wireless | K140551 | | Varex PaxScan 4336W v4 - Wireless | K183541 | | Varex PaxScan 4336W v4 + - Wireless | -- | | Thales Pixium 3543 DR-CS (Wireless) | K182517 | | IRAY VENU 1417V (Wireless) | -- | *Table 1 List of Solid State X-Rav Image Detectors * All the above mentioned Solid State X-Ray Image Detectors (Digital detectors) can be used with Dual Energy Subtraction feature. {5}------------------------------------------------ #### 5. Device Description: The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaqing. The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor. The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections. The following in Table 2 are the specific components for various configurations of the system. A complete system will consist of a selection of one of the devices in each category. | Component | Manufacture | Model | |------------------------------------------------------|-------------------------|--------------------| | Ceiling Mounted X-Ray Tube Suspension | Allengers | CSA FDX | | Vertical Bucky Stand | Allengers | VBS ADV | | Vertical Bucky Stand | Allengers | VBS M XL | | Patient Table - Fixed | Allengers | Floatex ADV | | Patient Table - Fixed | Allengers | Floatex | | Patient Table - Fixed | Allengers | Floatex XL | | Patient Table - Mobile | Allengers | MobiT 6C | | Patient Table - Mobile | Allengers | MobiT 4C | | Patient Table - Mobile | Allengers | MobiT C | | X-Ray Generator | Allengers | XGEN-80R | | X-Ray Generator | Allengers | XGEN-65R | | X-Ray Tube | Varex | A192 | | X-Ray Tube | Varex | A292 | | X-Ray Tube | Varex | G292 | | X-Ray Tube | Varex | G1092 | | X-Ray Tube | Varex | RAD14 | | Beam Limiting Device | Ralco | R225 ACS | | Solid State X-Ray Image Detector - Fixed | Varex | PaxScan 4343R | | Solid State X-Ray Image Detector - Fixed | Varex | PaxScan 4343R v3 | | Solid State X-Ray Image Detector -<br>Portable Wired | Varex | PaxScan 4336R | | Solid State X-Ray Image Detector -<br>Portable Wired | Varex (Perkin<br>Elmer) | XRPAD 4343F | | Solid State X-Ray Image Detector - Fixed | Varex | PaxScan 4343CB | | Solid State X-Ray Image Detector - Fixed | Thales | Pixium Rad 4343 CE | Table 2 Combination Detail {6}------------------------------------------------ | Solid State X-Ray Image Detector - Fixed | IRAY | VENU 1717X | |------------------------------------------|-------------------------|--------------------| | Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4336W | | Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4336W V4 | | Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4336W V4 + | | Solid State X-Ray Image Detector – WiFi | Varex (Perkin<br>Elmer) | XRPAD 4336 | | Solid State X-Ray Image Detector - WiFi | Thales | Pixium 3543DR-CS | | Solid State X-Ray Image Detector - WiFi | IRAY | MARS 1417V | ### 6. Technological Characteristics Comparison to Predicate Device: The Subject device DigiX FDX design is based on the Allenger's DigiX FDX (K162529) including the system control, Indication for use and mechanical design. The modifications do not affect the intended use of the device the subject device and predicate device are based on the following same fundamental scientific technologies elements: - Energy emission to the patient X-Ray ● - Power requirement, Environmental requirement ● - . Mechanism to generate X-Rav - . Mechanism to acquire, process and store image data - Use of the hardware components ● - Use of software processing This 510(k) submission describes some modifications to the previously cleared predicate devices the DigiX FDX (K162529). The changes to the predicate DigiX FDX (K162529) include: ### System Software Synergy DR FDX Synergy DR FDX comparable to ECOM DROC (K130883) added with same functionality along with below said additional features. - . Operating System: Updated operating system from Windows 7 to Windows 10 - Automatic Stitching: Image stitching is the process of overlapping two or more images taken at different viewpoints and different times to generate a wider viewing panoramic image. - . **Dual Energy Subtraction: Dual energy subtraction (DES) radiography, a new added feature for software Synergy DR FDX, is a technique which aims to improve the diagnostic value of an X-Ray by separating soft tissue from bones, producing two different images. ** Dual Energy Subtraction feature can be used with all the Solid State X-Ray Image detectors (Digital detectors) listed in table 1 of this 510(k) summary. {7}------------------------------------------------ ### Component Change - X-Ray Tube : RAD-14 (Make : Varex Imaging) is added ● - . 43x36cm Wireless Detectors are added (Listed below), - Paxscan 4336W v4 manufactured by Varex Imaging ● - . Pixium 3543 DR-CS manufactured by Thales. - . MARS 1417V manufactured by IRAY technology. - . 43x43cm Fixed Detectors are added (Listed below), - Paxscan 4343R v3 manufactured by Varex imaging ● - Pixium Rad 4343 C-E manufactured by Thales ● - VENU 17171X manufactured by IRAY technology. ● - Paxscan 4343CB manufactured by Varex Imaging. ● - . Wireless IR Remote (Optional) added. - Monitor with 19" or more in size (touch and Non touch) added. - Patient Table: Minor changes in mechanical dimensions and increase the ● load carrying capacity of patient tables. ### Others Change - EMC (Electromagnetic Compatibility) was tested according to IEC ed. 4.0. ● - Combination Name change (Refer Table 4 for more detail) ● - Brand Name M/s Varian to M/s Varex imaging (FPD & X-Ray Tube ● Manufacturer) ### 7. Indications for Use: The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes. {8}------------------------------------------------ #### 8. Substantial Equivalence: The DigiX FDX radiographic X-Ray system is substantially equivalent to the commercially available primary predicate Allenger's DigiX FDX Cleared March 3, 2017 with K162529 Mechanical dimensions was slightly change, however the changes doesn't impact the intended use of device. Table 3 provides primary and secondary predicate comparable information | Predicate Device(s) Name<br>and Manufacture | 510(K)<br>Number | Clearance Date | Comparable<br>Properties | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------|----------------------------------------------------------------| | Primary Predicate Device<br>DigiX FDX<br>Product Code: KPR<br>Address: Allengers<br>Medical Systems Ltd.<br>Bhankharpur, Mubarakpur<br>Road, Derabassi, Distt<br>Mohali-140507 India | K162529 | 3/3/2017 | • Technical Design<br>• Mechanical Design<br>• System Software | | Secondary Predicate<br>Device: Ysio<br>Product Code: KPR<br>Address: Siemens Medical<br>Solutions USA, Inc,<br>51 valley stream, Parkway<br>E-50, Malvern PA, 19335-<br>1406 | K081722 | 8/25/2008 | • Technical Design<br>• Mechanical Design<br>• System Software | #### Table 3 Predicate Device Comparable Properties {9}------------------------------------------------ | | | Table 4: Functional and Specification Differences | | |--|--|----------------------------------------------------|--| |--|--|----------------------------------------------------|--| | Feature | Subject Device<br>DigiX FDX | Predicate 1<br>DigiX FDX | Predicate 2<br>Siemens Ysio | Comparison<br>Results | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | 1. 510(K) | K192541 | K162529 | K081722 | Same | | 2. Classification | | | | | | Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | Clinical Characteristics | | | | | | 3. Indication for Use | | | | | | Indications for<br>Use | The DigiX FDX<br>radiographic systems<br>are used in hospitals,<br>clinics and medical<br>practices. DigiX FDX<br>enables radiographic<br>exposure of the whole<br>body including: Skull,<br>chest, abdomen, and<br>extremities and may be<br>used on pediatric, adult<br>and bariatric patients. It<br>can also be used for<br>intravenous, small<br>interventions (like<br>biopsy, punctures, etc.)<br>and emergency<br>(trauma critical ill)<br>applications.<br>Exposure may be taken<br>with the Patient's<br>sitting, standing, or in<br>the prone/supine<br>position.<br>The DigiX FDX System<br>is not meant for<br>mammography.<br>The DigiX FDX uses an<br>integrated or portable<br>or fixed or Wi-Fi digital<br>detector for generating<br>diagnostic images by<br>converting X-Ray into<br>electronics signals. | The DigiX FDX<br>radiographic<br>systems are used<br>in hospitals, clinics<br>and medical<br>practices. DigiX<br>FDX enables<br>radiographic<br>exposure of the<br>whole body<br>including: Skull,<br>chest, abdomen,<br>and extremities<br>and may be used<br>on pediatric, adult<br>and bariatric<br>patients. It can<br>also be used for<br>intravenous, small<br>interventions (like<br>biopsy, punctures,<br>etc.) and<br>emergency<br>(trauma critical ill)<br>applications.<br>Exposure may be<br>taken with the<br>Patient's sitting,<br>standing, or in the<br>prone/supine<br>position.<br>The DigiX FDX<br>System is not<br>meant for<br>mammography. | The Ysio (New RAD<br>Family) systems are<br>the radiographic<br>systems used in<br>hospitals, clinics, and<br>medical practices. Ysio<br>enables radiographic<br>and tomographic<br>exposures of the whole<br>body including: skull,<br>chest, abdomen, and<br>extremities and may be<br>used on pediatric, adult<br>and bariatric patients.<br>It can also be used for<br>intravenous, small<br>interventions (like<br>biopsy, punctures, etc.)<br>and emergency<br>(trauma, critical ill)<br>applications.<br>Exposures may be<br>taken with the patient<br>sitting, standing, or in<br>the prone position. The<br>Ysio system is not<br>meant for<br>mammography. The<br>Ysio uses an<br>integrated or portable<br>digital detector for<br>generating diagnostic<br>images by converting<br>X-Rays into electronic<br>signals. Ysio is also<br>designed to be used | Same as<br>predicate 1 | | | DigiX FDX is also<br>designed to be used<br>with conventional<br>film/screen or<br>Computed<br>Radiography (CR)<br>Cassettes. | The DigiX FDX<br>uses an integrated<br>or portable or fixed<br>or Wi-Fi digital<br>detector for<br>generating<br>diagnostic images<br>by converting X-<br>Ray into<br>electronics<br>signals. DigiX FDX<br>is also designed to<br>be used with<br>conventional<br>film/screen or<br>Computed<br>Radiography (CR)<br>Cassettes. | with conventional<br>film/screen or<br>Computed<br>Radiography (CR)<br>Cassettes | | | Technical Characteristics | | | | | | 4. | Ceiling Mounted X-Ray Tube Suspension | | | | | Model | CSA FDX | CSAAdv & CSAFDX | Ysio | | | Longitudinal<br>travel | 300 cm | 300 cm | 346 cm | Same as<br>predicate 1 | | Transverse<br>travel | 200 cm | 200 cm | 220 cm | Same as<br>predicate 1 | | Vertical travel | 150 cm | 150 cm | 190 cm | Same as<br>predicate 1 | | Tube rotation<br>(horiz.) | $ \pm 180^\circ $ | $ \pm 180^\circ $ | $ \pm 180^\circ $ | Same | | Tube rotation<br>(vert.) | $ \pm 180^\circ $ | $ \pm 180^\circ $ | $ \pm 180^\circ $ | Same | | Fully<br>automated | Yes | Yes | Yes | Same | | Digital<br>Readout | Yes | Yes | Yes | Same | | 5. Vertical Bucky Stand | | | | | | Model | VBS ADV | VBSAdv | BWS with Max static | Same as | | Vertical travel | 125 cm | 125 cm | 145 cm | predicate 1 | | Model | VBS M XL | VBS MXL | BWS wi-D | Same as | | Vertical travel | 162 cm | 162 cm | 141 cm | predicate 1 | | 6. Patient Table |…