(30 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on demonstrating substantial equivalence to predicate devices rather than defining specific quantitative performance metrics as "acceptance criteria" for a new AI/software feature in the way clinical performance studies usually do. Instead, the "acceptance criteria" are implied to be that the modifications do not negatively impact safety or effectiveness, and that the device performs comparably to the predicate devices and meets relevant safety standards.
For the new features explicitly mentioned (Automatic Stitching and Dual Energy Subtraction), the document states they add functionality without affecting patient safety or effectiveness. For the other components, the criteria are often "Same" or "Similar functionality with same imaging results" or "doesn't affect the safety or effectiveness."
To represent this in a table, we'll extract performance comparisons from the "Functional and Specification Differences" table (Table 4) and the "Justification for Differences" (Table 5).
| Feature / Acceptance Criteria | Reported Device Performance (Subject Device: DigiX FDX) | Comparison to Predicate 1 (DigiX FDX K162529) | Comparison to Predicate 2 (Siemens Ysio K081722) | Justification (Implied Acceptance) |
|---|---|---|---|---|
| Clinical Characteristics / Indications for Use | Same as predicate | Same | Same | No new indications for use; no new potential hazards. |
| Mechanical Design (e.g., travel ranges for Ceiling Mounted X-Ray Tube Suspension, Vertical Bucky Stand, Patient Table) | Various models with specified travel ranges (e.g., Longitudinal travel: 300 cm, Transverse travel: 200 cm for CSA FDX) | Mostly "Same as predicate 1" or minor differences with "Similar Functionality" | Differences noted but generally "Same as predicate 1" or "Similar Functionality" | Minor changes do not impact intended use, safety, or effectiveness. |
| Patient Table Maximum Patient Capacity | 250 kg (551 lbs) for FloatexXL, Floatex ADV, MobiT 6C, MobiT 4C; 200 kg (440 lbs) for MobiT C | Increased from 200 kg (440 lbs) for some models | Higher (300 kg for Predicate 2) or NA | Capable of carrying higher patient weight without raising new risks (Note 1). |
| X-Ray Generator (kW rating, kV range, mA max, mAs range, APR programming) | Specified ranges and capabilities (e.g., 65 kW/80 kW, 40-150 kV, 650/800 mA) | "Same" for most parameters; mAs range same as predicate 1 | "Same" for some parameters; mAs range "NS" for predicate 2 | Consistent with predicate devices. |
| IR Remote | Yes (Wireless IR Remote available) | No | NA | New feature, but same functionality as wired hand switch, EMC compliant, meets 21 CFR (Note 3). No new safety/effectiveness issues. |
| X-Ray Tube (Various Varex models: G1092, G292, A292, A192, RAD 14) | Various models with specified focal spots, heat units, target angles, target diameters, target materials. | Mostly "Same as predicate 1" or "Similar Functionality" (e.g., for RAD 14, target diameter different but essentially same imaging results) | Differences noted but generally "Same as predicate 1" or similar. | Already cleared by FDA, essentially same imaging results, do not affect safety or effectiveness (Note 4). |
| Beam Limiting Device (Construction, CFR 211020.31, Automatic) | Multi-leaf, Compliant, Yes | Same | Same | Compliant with standards. |
| Solid State X-Ray Image Detector (Various models from Varex, Thales, IRAY) | Various models with specified panel types, active areas, pixel pitches, pixel matrices, scintillators, limiting resolutions. | Mostly "Same as predicate 1" or "Similar Functionality" or "Same imaging results." | Mostly "Same as predicate 2" or "Similar Functionality" or "Same imaging results." | Previously cleared by FDA, does not raise safety concerns or affect effectiveness (Note 5, 6, 7). |
| Viewing Monitors | 19 inch or more (Touch and Non Touch) | 19 inch Monitor | 19 inch Monitor | Similar functionality, same imaging results, doesn't affect patient safety or effectiveness (Note 8). |
| Software Operating System | Microsoft Windows 7 / Microsoft Window 10 | Microsoft Windows 7 / Microsoft Window 10 | Microsoft Windows 7 | Similar Functionality (Note 9). Updated OS. |
| Automatic Image Stitching (Software Feature) | Automatic | Manual | Manual | New functionality. Software documentation for moderate level of concern included. No new safety/effectiveness issues (Note 9). |
| Dual Energy Subtraction (Software Feature) | Yes | No | No | New feature. Improves radiologist's ability to detect/diagnose chest lesions, makes calcification more conspicuous. Doesn't affect patient safety or effectiveness (Note 10). |
| EMC/Electrical Safety | Compliant with IEC Standards (60601-1, 60601-1-2, 60601-1-3, 60601-2-54, ISO 14971, 62366-1, 62304) | Implicitly comparable | Implicitly comparable | All testing completed and found acceptable. Hazards mitigated. Substantially equivalent to predicate device in safety and effectiveness. |
| Software Level of Concern | Moderate Level of Concern | Moderate Level of Concern (for predicate software DROC K130883) | Moderate Level of Concern (for predicate software DROC K130883) | Software documentation provided per FDA guidance. No new safety/effectiveness issues (Note 9). |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing."
- "Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission."
- "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system."
The document does NOT specify a sample size for any test set (clinical or otherwise) in terms of patient data or images used for validation of the radiographic system itself, nor does it mention data provenance (country of origin, retrospective/prospective). It primarily relies on hardware and software equivalence, and compliance with industry standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The document explicitly states "Clinical testing is not applicable." Therefore, there was no clinical study conducted that would necessitate expert readers to establish ground truth for a test set. The evaluation focuses on technical performance and equivalence to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set requiring expert adjudication was performed, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document states "Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system." Therefore, there is no information on how much human readers improve with or without AI assistance. The new software features (Automatic Stitching, Dual Energy Subtraction) are presented as additional functionalities that don't affect safety or effectiveness, not as AI-assisted diagnostic tools requiring a comparative effectiveness study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a radiographic system, not an AI algorithm intended for standalone diagnostic performance. While it includes new software features (Automatic Stitching, Dual Energy Subtraction), these are integrated functionalities of the imaging system and not described as standalone diagnostic algorithms requiring independent performance evaluation without human interaction.
7. Type of Ground Truth Used
The "ground truth" for the evaluation is primarily based on:
- Compliance with technical specifications and design requirements: Functional testing, image performance testing.
- Adherence to safety and performance standards: IEC 60601 series, EN ISO 14971, IEC 62366-1, IEC 62304, 21 CFR 1020.30, 21 CFR 1020.31.
- Substantial equivalence to predicate devices: Demonstration that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Software documentation assessment: For the software components, including the new features, documentation was provided for a "Moderate Level of Concern" software as per FDA guidance.
No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used or required given the nature of this submission.
8. Sample Size for the Training Set
Not applicable. The document describes an X-ray imaging system, not an AI/ML device that requires a training set of data. The new software features (Automatic Stitching, Dual Energy Subtraction) are described as functionalities, not adaptive algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth to establish for it.
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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
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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) |
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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, MubarakpurRoad, Derabassi, Distt Mohali-140507India |
| Telephone No: | +91 1762-272600,+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 |
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-
- Secondary Predicate Device:
Secondary Device: Ysio
- Secondary Predicate Device:
| 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.
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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 -Portable Wired | Varex | PaxScan 4336R |
| Solid State X-Ray Image Detector -Portable Wired | Varex (PerkinElmer) | 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
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| 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 (PerkinElmer) | 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.
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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.
- Paxscan 4336W v4 manufactured by Varex Imaging ●
- . 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.
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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) Nameand Manufacture | 510(K)Number | Clearance Date | ComparableProperties |
|---|---|---|---|
| Primary Predicate DeviceDigiX FDXProduct Code: KPRAddress: AllengersMedical Systems Ltd.Bhankharpur, MubarakpurRoad, Derabassi, DisttMohali-140507 India | K162529 | 3/3/2017 | • Technical Design• Mechanical Design• System Software |
| Secondary PredicateDevice: YsioProduct Code: KPRAddress: Siemens MedicalSolutions USA, Inc,51 valley stream, ParkwayE-50, Malvern PA, 19335-1406 | K081722 | 8/25/2008 | • Technical Design• Mechanical Design• System Software |
Table 3 Predicate Device Comparable Properties
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| Table 4: Functional and Specification Differences | |||
|---|---|---|---|
| -- | -- | ---------------------------------------------------- | -- |
| Feature | Subject DeviceDigiX FDX | Predicate 1DigiX FDX | Predicate 2Siemens Ysio | ComparisonResults |
|---|---|---|---|---|
| 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 forUse | The DigiX FDXradiographic systemsare used in hospitals,clinics and medicalpractices. DigiX FDXenables radiographicexposure of the wholebody including: Skull,chest, abdomen, andextremities and may beused on pediatric, adultand bariatric patients. Itcan also be used forintravenous, smallinterventions (likebiopsy, punctures, etc.)and emergency(trauma critical ill)applications.Exposure may be takenwith the Patient'ssitting, standing, or inthe prone/supineposition.The DigiX FDX Systemis not meant formammography.The DigiX FDX uses anintegrated or portableor fixed or Wi-Fi digitaldetector for generatingdiagnostic images byconverting X-Ray intoelectronics signals. | The DigiX FDXradiographicsystems are usedin hospitals, clinicsand medicalpractices. DigiXFDX enablesradiographicexposure of thewhole bodyincluding: Skull,chest, abdomen,and extremitiesand may be usedon pediatric, adultand bariatricpatients. It canalso be used forintravenous, smallinterventions (likebiopsy, punctures,etc.) andemergency(trauma critical ill)applications.Exposure may betaken with thePatient's sitting,standing, or in theprone/supineposition.The DigiX FDXSystem is notmeant formammography. | The Ysio (New RADFamily) systems arethe radiographicsystems used inhospitals, clinics, andmedical practices. Ysioenables radiographicand tomographicexposures of the wholebody including: skull,chest, abdomen, andextremities and may beused on pediatric, adultand bariatric patients.It can also be used forintravenous, smallinterventions (likebiopsy, punctures, etc.)and emergency(trauma, critical ill)applications.Exposures may betaken with the patientsitting, standing, or inthe prone position. TheYsio system is notmeant formammography. TheYsio uses anintegrated or portabledigital detector forgenerating diagnosticimages by convertingX-Rays into electronicsignals. Ysio is alsodesigned to be used | Same aspredicate 1 |
| DigiX FDX is alsodesigned to be usedwith conventionalfilm/screen orComputedRadiography (CR)Cassettes. | The DigiX FDXuses an integratedor portable or fixedor Wi-Fi digitaldetector forgeneratingdiagnostic imagesby converting X-Ray intoelectronicssignals. DigiX FDXis also designed tobe used withconventionalfilm/screen orComputedRadiography (CR)Cassettes. | with conventionalfilm/screen orComputedRadiography (CR)Cassettes | ||
| Technical Characteristics | ||||
| 4. | Ceiling Mounted X-Ray Tube Suspension | |||
| Model | CSA FDX | CSAAdv & CSAFDX | Ysio | |
| Longitudinaltravel | 300 cm | 300 cm | 346 cm | Same aspredicate 1 |
| Transversetravel | 200 cm | 200 cm | 220 cm | Same aspredicate 1 |
| Vertical travel | 150 cm | 150 cm | 190 cm | Same aspredicate 1 |
| Tube rotation(horiz.) | $ \pm 180^\circ $ | $ \pm 180^\circ $ | $ \pm 180^\circ $ | Same |
| Tube rotation(vert.) | $ \pm 180^\circ $ | $ \pm 180^\circ $ | $ \pm 180^\circ $ | Same |
| Fullyautomated | Yes | Yes | Yes | Same |
| DigitalReadout | 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 | ||||
| Model | FloatexXL | FloatexXL | Bucky Table | |
| Type | 4-way floating top | 4-way floatingTop | 4-way floating top | Same |
| Longitudinaltravel | 95 cm | 95 cm, | NA | Same |
| Transversetravel | 25 cm | 25 cm, | NA | Same |
| Table toplocking | Electromagnetic | Electromagnetic | Electromagnetic | Same |
| Maximumpatientcapacity | 250 kg (551 lbs) | 200 kg (440 lbs) | 300 kg (660 lbs) | SimilarFunctionality(Note 1) |
| Model | Floatex ADV | Floatex+ | Bucky Table | |
| Type | 6-way floating top | 6-way floating top | 6-way floating top | Same |
| Longitudinaltravel | 95 cm | 53.5 cm | NA | SimilarFunctionality(Note 2) |
| Transversetravel | 25 cm | 18 cm | NA | SimilarFunctionality(Note 2) |
| Vertical travel | 26.5 cm | 26.5 cm | 29 cm | Same aspredicate 1 |
| Table toplocking | Electromagnetic | Electromagnetic | Electromagnetic | Same |
| Maximumpatientcapacity | 250 kg (551 lbs) | 200 kg (440 lbs) | 300 kg (660 lbs) | SimilarFunctionality(Note 1) |
| OptionalModel | Floatex | Floatex | NA | |
| Type | 4-way floating top | 4-way floating top | NA | Same |
| Longitudinaltravel | 53.5 cm | 53.5 cm | NA | Same |
| Transversetravel | 20 cm | 20 cm | NA | Same |
| Table toplocking | Electromagnetic | Electromagnetic | NA | Same |
| Maximumpatientcapacity | 250 kg (551 lbs) | 200 kg (440 lbs) | NA | SimilarFunctionality(Note 1) |
| OptionalModel | MobiT 6C | MobiT 6C | NA | |
| Type | Mobile with floatingtop | Mobile withfloating top | NA | Same |
| Longitudinaltravel | 60 cm | 60 cm | NA | Same |
| Transverseravel | 20 cm | 20 cm | NA | Same |
| Vertical travel | 40 cm | 40 cm | NA | Same |
| Table toplocking | Electromagnetic | Electromagnetic | NA | Same |
| Maximumpatientcapacity | 250 kg (551 lbs) | 200 kg (440 lbs) | NA | SimilarFunctionality(Note 1) |
| Optional | MobiT 4C | MobiT 4C | NA | |
| Model | ||||
| Type | Mobile with floatingtop | Mobile withfloating top | NA | Same |
| Longitudinaltravel | 60 cm | 60 cm | NA | Same |
| Transversetravel | 20 cm | 20 cm | NA | Same |
| Table toplocking | Electromagnetic | Electromagnetic | NA | Same |
| Maximumpatientcapacity | 250 kg (551 lbs) | 200 kg (440 lbs) | NA | SimilarFunctionality(Note 1) |
| OptionalModel | Mobit C | Mobit C | NA | |
| Type | Mobile | Mobile | NA | Same |
| Table top | Fixed | Fixed | NA | Same |
| Maximumpatientcapacity | 200 kg (440 lbs) | 200 kg (440 lbs) | NA | Same |
| 7. X-Ray Generator | ||||
| Kilowattrating | 65 kW80 kW | 65 kW standard80 kW optional | 65 kW standard80 kW optional | Same |
| kV minimum(65/80) | 40/40 kV | 40/40 kV | 40/40 kV | Same |
| kV maximum(65/80) | 150/150 kV | 150/150 kV | 150/150 kV | Same |
| mAmaximum @100kV(65/80) | 650/800 mA | 650/800 mA | 650/800 mA | Same |
| mAs Range(65/80) | 800/10000mAs | 800/1000mAs | NS | Same aspredicate 1 |
| APRprogramming | Yes | Yes | Yes | Same |
| IR Remote | Yes | No | NA | New Feature(Note 3) |
| 8. X-Ray Tube | ||||
| Tube Type | Varex Imaging G1092 | Varex ImagingG1092 | Siemens OPTITOP | Same aspredicate 1 |
| Focal Spotsizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | 0.6mm / 1.0mm | Same aspredicate 1 |
| Heat Units | 1 MHU | 1 MHU | 783 KHU | Same aspredicate 1 |
| Target Angle | 12° | 12° | 12° | Same |
| TargetDiameter | 108 mm | 108 mm | 100 mm | Same aspredicate 1 |
| TargetMaterial | RTM | RTM | RTM | Same |
| OptionalTube | Varex Imaging G292 | Varex ImagingG292 | Siemens OPTILIX | |
| Focal Spotsizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | 0.6mm / 1.0mm | Same aspredicate 1 |
| Heat Units | 600 kHU | 600 KHU | 600 kHU | Same |
| Target Angle | 12° | 12° | 16° | Same aspredicate 1 |
| TargetDiameter | 102 mm | 102 mm | 100 mm | Same aspredicate 1 |
| TargetMaterial | RTM | RTM | RTM | Same |
| OptionalTube | Varex Imaging A292 | Varex ImagingA292 | NA | |
| Focal Spotsizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | NA | Same |
| Heat Units | 400 kHU | 400 kHU | NA | Same |
| Target Angle | 12° | 12° | NA | Same |
| TargetDiameter | 102 mm | 102 mm | NA | Same |
| TargetMaterial | RTM | RTM | NA | Same |
| OptionalTube | Varex Imaging A192 | Varex ImagingA192 | NA | |
| Focal Spotsizes | 0.6mm / 1.2mm | 0.6mm / 1.2mm | NA | Same |
| Heat Units | 300 KHU | 300 KHU | NA | Same |
| Target Angle | 12° | 12° | NA | Same |
| TargetDiameter | 102 mm | 102 mm | NA | Same |
| TargetMaterial | RTM | RTM | NA | Same |
| OptionalTube | Varex Imaging RAD14 | Varex ImagingA192 | NA | |
| Focal Spotsizes | 0.6mm / 1.2 mm | 0.6mm / 1.2mm | NA | Same |
| Heat Units | 300 kHU | 300 kHU | NA | Same |
| Target Angle | 12° | 12° | NA | Same |
| TargetDiameter | 80 mm | 102 mm | NA | SimilarFunctionality(Note 4) |
| TargetMaterial | RTM | RTM | NA | Same |
| Beam Limiting Device | ||||
| Construction | Multi-leaf | Multi-leaf | Multi-leaf | Same |
| CFR211020.31 | Compliant | Compliant | Compliant | Same |
| Automatic | Yes | Yes | Yes | Same |
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
| Model | XRPAD 4343 F | XRPAD 4343F | Trixell Pixium 4600 | |
|---|---|---|---|---|
| FDA Cleared | Yes, K142698 | Yes, K142698 | Yes, K093066 | |
| Panel Type | Single substrateamorphous siliconactive TFT/diode array | Single substrateamorphoussilicon activeTFT/diode array | Amorphous Silicon | Same aspredicate 1 |
| Active area | 432 mm X 432 mm | 432 mm X 432mm | 429 mm X 429 mm | Same aspredicate 1 |
| Pixel pitch | 100 μm | 100 μm | 143 μm | Same aspredicate 1 |
| Pixel matrix | 4318 X 4320 | 4318 X 4320 | 3001 x 3001 | Same aspredicate 1 |
| Scintillator | Direct depositionCsl:TI | Direct depositionCsl:TI | Cesium lodide | Same orsimilar withsame imagingresults |
| Limitingresolution | 5 lp/mm | 5 lp/mm | 3.6 lp/mm | Same aspredicate 1 |
| OptionalModel | Varex's PaxScan4336R | Varex's PaxScan4336R | Thales Pixium 3543 | |
| FDA Cleared | Yes, K130318 | Yes, K130318 | Yes, K093066 | |
| Panel Type | Amorphous Siliconwith Charge WellPixel™ Technology | AmorphousSilicon withCharge WellPixel™Technology | Pixium© Csl coupled toTFT matrix aSitechnology | Same aspredicate 1 |
| PixelArea(Active) | 353 mm X 424mm | 353mm X 424mm | 342 mm X 432 mm | Same aspredicate 1 |
| Pixel pitch | 139 μm | 139 μm | 144 μm | Same aspredicate 1 |
| Pixel matrix | 2560 X 3072 | 2560 X 3072 | 2372 X 3000 | Same aspredicate 1 |
| Scintillator | Direct Deposit Csl,Detached Csl, DRZPlus | Direct DepositCsl, DetachedCsl, DRZ Plus | Cesium lodide | Same aspredicate 1 |
| Limitingresolution | 3.6 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same |
| Model | XRPAD 4336 | XRPAD 4336 | Thales Pixium 3543 | |
| FDA Cleared | Yes, K140551 | Yes, K140551 | Yes, K093066 | |
| Panel Type | Single substrateamorphous siliconactive TFT/diode array | Single substrateamorphoussilicon activeTFT/diode array | Pixium© Csl coupled toTFT matrix aSitechnology | Same aspredicate 1 |
| Active Area | 355 mm X 432 mm | 355 mm X 432mm | 342 mm X 432 mm | Same aspredicate 1 |
| Pixel pitch | 100 μm | 100 μm | 144 μm | Same aspredicate 1 |
| Pixel matrix | 3556 X 4320 | 3556 X 4320 | 2372 X 3000 | Same as |
| predicate 1 | ||||
| Scintillator | Direct depositionCsI:TI | Direct depositionCsI:TI | Cesium Iodide | Same aspredicate 1 |
| Limiting resolution | 5 lp/mm | 5 lp/mm | 3.6 lp/mm | Same aspredicate 1 |
| Optional Model | Varex's PaxScan4336W | Varex's PaxScan4336W | Thales Pixium 3543 | |
| FDA Cleared | Yes, K142049 | Yes, K142049 | Yes, K093066 | |
| Panel Type | Amorphous Silicon | Amorphous Silicon | Pixium© Csl coupled toTFT matrix aSitechnology | Same aspredicate 1 |
| Active Area | 353 mm X 424 mm | 353 mm X 424 mm | 342 mm X 432 mm | Same aspredicate 1 |
| Pixel pitch | 139 μm | 139 μm | 144 μm | Same aspredicate 1 |
| Pixel matrix | 2560 X 3072 | 2560 X 3072 | 2372 X 3000 | Same aspredicate 1 |
| Scintillator | Direct Deposit Csl,DRZ + | Direct DepositCsl, DRZ + | Cesium Iodide | Same aspredicate 1 |
| Limiting resolution | 3.6 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same |
| Optional Model | Varex's PaxScan4336W v4 | Varex's PaxScan4336W | Thales Pixium 3543 | |
| FDA Cleared | Yes, K183541 | Yes, K142049 | Yes, K093066 | |
| Panel Type | Amorphous Siliconwith TFT/PIN diodeTechnology | Amorphous Silicon | Pixium© Csl coupled toTFT matrix aSitechnology ) | Similar withsame imagingresults |
| Active Area | 339 mm X 424 mm | 353 mm X 424 mm | 342 mm X 432 mm | SimilarFunctionality(Note 5) |
| Pixel pitch | 139 μm | 139 μm | 144 μm | Same aspredicate 1 |
| Pixel matrix | 2476 X 3072 | 2560 X 3072 | 2372 X 3000 | SimilarFunctionality(Note 5) |
| Scintillator | Csl, DRZ + | Csl, DRZ + | Cesium lodide(CSI:Ti) | Same aspredicate 1 |
| Limiting resolution | 3.6 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same |
| Optional Model | Thales Pixium 3543DR-CS | Varex's PaxScan4336W | Thales Pixium 3543 | |
| FDA Cleared | Yes, K182517 | Yes, K142049 | Yes, K093066 | |
| Panel Type | Pixium® Csl coupledto TFT matrix a-Sitechnology | Amorphous Silicon | Pixium© Csl coupled toTFT matrix aSitechnology | Same aspredicate 2 |
| Active Area | 350mm x430 mm | 353 mm X 424 mm | 342 mm X 432 mm | SimilarFunctionality(Note 5) |
| Pixel pitch | 160 µm | 139 µm | 144 µm | SimilarFunctionality(Note 5) |
| Scintillator | Cesium Iodide(CSI:Ti) | CsI, DRZ + | Cesium Iodide | Same |
| OptionalModel | Varex's PaxScan4343R | Varex's PaxScan4343R | Trixell Pixium 4600 | |
| FDA Cleared | Yes, K130318 | Yes, K130318 | Yes, K093066 | |
| Panel Type | Amorphous Siliconwith Charge WellPixel™Technology | AmorphousSilicon withCharge WellPixel™Technology | Amorphous Silicon | Same aspredicate 1 |
| Active Area | 424 mm × 424 mm | 424 mm × 424 mm | 429 mm × 429 mm | Same aspredicate 1 |
| Pixel pitch | 139 µm | 139 µm | 143 µm | Same aspredicate 1 |
| Pixel matrix | 3072 × 3072 | 3072 × 3072 | 3001 × 3001 | Same aspredicate 1 |
| Scintillator | Direct Deposit CsI,Detached CsI, DRZPlus | Direct DepositCsI, DetachedCsI, DRZ Plus | Cesium Iodide | Same aspredicate 1 |
| Limitingresolution | 3.6 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same |
| OptionalModel | VENU 1717X | Varex Paxscan4343R | Trixell Pixium 4600 | |
| Panel Type | Amorphous Silicon | AmorphousSilicon withCharge WellPixel™Technology | Amorphous Silicon | Same aspredicate 2 |
| Active Area | 427 × 427 mm | 424 mm × 424 mm | 429 mm × 429 mm | Essentially theSame imagingArea doesn'taffect thepatient safetyoreffectiveness. |
| Pixel pitch | 139 µm | 139 µm | 143 µm | Same aspredicate 1 |
| Pixel matrix | 3072 × 3072 | 3072 × 3072 | 3001 × 3001 | Same aspredicate 1 |
| Scintillator | CsI | Direct DepositCsI, DetachedCsI, DRZ Plus | CsI | Same aspredicate 2 |
| Limitingresolution | 3.6 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same |
| OptionalModel | Varex's PaxScan4343R v3 | Varex's PaxScan4343R | Trixell Pixium 4600 | |
| FDA Cleared | Yes, K183541 | Yes, K130318 | Yes, K093066 | |
| Panel Type | Amorphous Siliconwith PIN Technology | Amorphous Silicon withCharge Well Pixel™Technology | Amorphous Silicon | Same orsimilar withsame imagingresults |
| Active Area | 424 mm X 424 mm | 424 mm X 424 mm | 429 mm X 429 mm | Same aspredicate 1 |
| Pixel pitch | 139 µm | 139 µm | 143 µm | Same aspredicate 1 |
| Pixel matrix | 3072 X 3072 | 3072 X 3072 | 3001 x 3001 | Same aspredicate 1 |
| Scintillator | CsI, DRZ+ | Direct DepositCsI, DetachedCsI, DRZ Plus | Cesium lodide | Same orSimilar withsame imagingresults |
| Limiting resolution | 3.6 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same |
| Optional Model | Pixium RAD 4343 C-E | Varex's PaxScan 4343R | Trixell Pixium 4600 | |
| FDA Cleared | Yes, K181279 | Yes, K130318 | Yes, K093066 | |
| Panel Type | Amorphous Silicon | Amorphous Silicon withCharge Well Pixel™Technology | Amorphous Silicon | Same aspredicate 2 |
| Active Area | 423.3 x 425.4 | 424 mm X 424 mm | 429 mm X 429 mm | SimilarFunctionality(Note 5) |
| Pixel pitch | 148 µm | 139 µm | 143 µm | SimilarFunctionality(Note 5) |
| Pixel matrix | 2860 X 2874 | 3072 X 3072 | 3001 x 3001 | SimilarFunctionality(Note 5) |
| Scintillator | Cesium lodide(CSI) | Direct DepositCsI, DetachedCsI, DRZ | Cesium lodide | Same aspredicate 2 |
| Optional Model | Paxscan 4343CB | Varex's PaxScan 4343R | Trixell Pixium 4600 | |
| FDA Cleared | Yes, K190373 | Yes, K130318 | Yes, K093066 | |
| Panel Type | Amorphous Silicon | Amorphous Silicon withCharge Well Pixel™Technology | Amorphous Silicon | Similar withSame imagingresult |
| Active Area | 427mm x 427 mm | 427mm x 427 mm | 429 mm X 429 mm | Same aspredicate 1 |
| Pixel pitch | 139 µm | 139 µm | 143 µm | Same as |
| predicate 1 | ||||
| Pixel matrix | 3072 X 3072 | 3072 X 3072 | 3001 x 3001 | Same aspredicate 1 |
| Scintillator | Integral columnarCsl:TI | Direct DepositCsl, DetachedCsl, DRZ | Cesium lodide | SimilarFunctionality(Note 5) |
| OptionalModel | Varex's PaxScan4336W v4 + | Varex's PaxScan4336W | Thales Pixium 3543 | |
| Panel Type | Amorphous Siliconwith TFT/PIN diodeTechnology | AmorphousSilicon withTFT/PIN diodeTechnology | Pixium© Csl coupled toTFT matrix aSitechnology | Same aspredicate 1 |
| Active Area | 339 mm X 424 mm | 353 mm X 424mm | 342 mm X 432 mm | SimilarFunctionality(Note 6) |
| Pixel pitch | 139 µm | 139 µm | 144 µm | Same aspredicate 1 |
| Pixel matrix | 2476 X 3072 | 2560 X 3072 | 2372 X 3000 | SimilarFunctionality(Note 6) |
| Scintillator | Csl, DRZ + | Csl, DRZ + | Cesium lodide | Same aspredicate 1 |
| Limitingresolution | 3.6 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same |
| OptionalModel | MARS 1417V | Varex's PaxScan4336W | Thales Pixium 3543 | |
| Panel Type | a-Si (AmorphousSilicon) TFT | AmorphousSilicon | Pixium© Csl coupled toTFT matrix aSitechnology | Same orSimilarFunctionality(Note 7) |
| Active Area | 346 X 420 | 353 mm X 424mm | 342 mm X 432 mm | Same orSimilarFunctionality(Note 7) |
| Pixel pitch | 150 µm | 139 µm | 144 µm | Same orSimilarFunctionality(Note 7) |
| Pixel matrix | 2304 x 2800 | 2560 X 3072 | 2372 X 3000 | Same orSimilarFunctionality(Note 7) |
| Scintillator | Csl | Csl, DRZ + | Cesium lodide | Same aspredicate 2 |
| LimitingResolution | 3.4 lp/mm | 3.6 lp/mm | 3.6 lp/mm | Same orSimilarFunctionality(Note 7) |
Allengers Medical Systems Limited DigiX FDX 510(k)
Section 5-0
{15}------------------------------------------------
{16}------------------------------------------------
{17}------------------------------------------------
{18}------------------------------------------------
{19}------------------------------------------------
| 11. Viewing Monitors | 19 inch or more(Touch and NonTouch) | 19 inch Monitor | 19 inch Monitor | SimilarFunctionality( Note 8 ) | |
|---|---|---|---|---|---|
| 12. Software Feature | |||||
| Model | SynergyDR FDX | DROC | DROC | DelWorks DR System | |
| FDA Cleared | K130883 | Yes, K130883 | Yes, K140825 | ||
| OperatingSystem | MicrosoftWindows7/MicrosoftWindow10 | MicrosoftWindows7/ MicrosoftWindow10 | MicrosoftWindows7 | Microsoft Windows7 | SimilarFunctionality(Note 9) |
| Network | Ethernet/Wifi | Ethernet/Wifi | Ethernet/ Wifi | Ethernet/ Wifi | Same |
| User | Mouse,Keyboard | Mouse,Keyboard, | Mouse,Keyboard, | Mouse, Keyboard, | Same |
| Interaction/input | TouchMonitor, | TouchMonitor, | Touch Monitor, | Touch Monitor, | Same |
| Multi-user | Available | Available | Available | Available | Same |
| Import/Exportimages | Yes | Yes | Yes | Yes | Same |
| Acquisitiondevice | ComputedRadiographyDigital X-RayDetector | ComputedRadiography DigitalX-RayDetector | ComputedRadiographyDigital X-RayDetector | ComputedRadiography Digital X-Ray Detector | Same |
| ImageInterferences | Detectordependent | Detectordependent | Detectordependent | Detector dependent | Same |
| ImageOrganization | YesPatientID/Name/StudyinstanceUIDPatientID/Name/StudyinstanceUID | YesPatientID/Name/StudyinstanceUIDPatientID/Name/StudyinstanceUID | YesPatientID/Name/Studyinstance UIDPatientID/Name/Studyinstance UID | YesPatientID/Name/Studyinstance UIDPatientID/Name/Studyinstance UID | Same |
| ImageSearchavailable | Yes | Yes | Yes | Yes | Same |
| ImageStorage | Yes | Yes | Yes | Yes | Same |
| Database | Yes | Yes | Yes | Yes | Same |
| storage | |||||
| Database Software | MS-Access | MS-Access | MS-Access | MS-Access | Same |
| Image Viewing | Yes | Yes | Yes | Yes | Same |
| Image measurement | Yes | Yes | Yes | Yes | Same |
| Image Annotation | Yes | Yes | Yes | Yes | Same |
| Image Operation | Yes | Yes | Yes | Yes | Same |
| Image Stitching | Automatic | Manual | Manual | Manual | Similar Functionality (Note 9) |
| Same Security | Yes(Priority by User) | Yes(Priority by User) | Yes(Priority by User) | Yes(Priority by User) | Same |
| DICOM 3.0 Compatibility | Yes | Yes | Yes | Yes | Same |
| Generator Control | Yes | Yes | Yes | Yes | Same |
| Generator Control Protocols | Generator dependent | Generator dependent | Generator dependent | Generator dependent | Same |
| Raw image Data Processing | Yes | Yes | Yes | Yes | Same |
| Post image data processing | Yes | Yes | Yes | Yes | Same |
| RIS code manager | Yes | Yes | Yes | Yes | Same |
| Dual Energy Subtraction | Yes | No | No | No | New Feature added (Note 10) |
| 13. Biological Characteristics | |||||
| Table Top Material | Carbon Composite Material | Carbon Composite Material | Carbon Composite Material | Same |
{20}------------------------------------------------
Table 5 Justification for Differences
| Note | Description |
|---|---|
| Note 1 | Allengers DigiX FDX (Subject Device) is capable for carrying patient weight up to250kg without raising any new risk related to patient safety or effectiveness. |
| Note 2 | Patient table (Floatex ADV) modified with more travel which provide full patientcoverage which doesn't affect the safety or effectiveness of device. |
| Note 3 | Optional Wireless IR Remote (make Tech switch) has same functionality as wiredhand switch for Exposure. Wireless version doesn't raise any new safety oreffectiveness issue. This feature is in EMC compliant and meet all necessaryrequirements pertaining to hand switch design as stated in 21 CFR |
| Note 4 | Varex Rad 14 X-Ray tube is new X-Ray tube for existing device. However, the X-Ray tube used by subject device is already cleared by FDA under Stationary Digitalradiography X-Ray device under 510(K) number K183541. Having same focal spotwith different X-Ray tube loading and target diameter which provide essentially thesame imaging results, which doesn't affect the safety or effectiveness. |
| Note 5 | The subject device utilizes different X-Ray flat panel detectors; however, the flatpanel detectors used by the subject device are already previously cleared by theFDA and does not raise the level of safety concern and affect any effectiveness.The relevant 510(k) approval number are K183541, K181279 & K182517 |
| Note 6 | New Detector Paxscan 4336W v4 + added in subject device. The flat paneldetector have all the technical specifications like Image area, Pixel Pitch, Activearea, resolution same to detector Paxscan 4336 W v4 (Previously cleared under510 (K) No. K183541) with light weight facility. The new additional Flat paneldetector (Varex Paxscan 4336W v4+) doesn't affect the patient safety oreffectiveness. |
| Note 7 | The Subject Device utilized different Flat panel X-Ray detector (i.e. MARS 1417V),However the flat panel detector used by subject device is updated version ofpreviously cleared FPD having 510(K) number K161730 with same imaging area,pixel pitch and same spatial resolution. The new additional Flat panel detector(MARS 1417V) doesn't affect the patient safety or effectiveness. |
| Note 8 | Monitors with 19" or more in sizes (Touch and Non touch) are utilized in subjectdevice with same imaging results which doesn't affect the patient safety oreffectiveness. |
| Note 9 | The subject device utilizes additional System software (SYNERGY DR FDX) withsame and updated functionalities like automatic Image stitching, Dual Energyfeature and update operating system. However Software Documentation for aModerate Level of Concern software per FDA's Guidance Document "guidance forthe Content of Premarket Submissions for Software Contained in Medical Devices"issued on May 11, 2005 is also included as part of this submission. The newsoftware doesn't raise the level of safety concern and affect any effectiveness. |
| Note 10 | Dual-energy subtraction chest radiography improves the radiologist's ability todetect and accurately diagnose a wide variety of chest lesions. The majoradvantage of this technique is that it makes calcification more conspicuous, anessential aid in characterizing pulmonary nodules. Thus this new feature doesn'taffect the patient safety or effectiveness. |
{21}------------------------------------------------
9. Reason for Submission
Modification of cleared device
{22}------------------------------------------------
10. Non-Clinical and Clinical Testing:
Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. All devices subject to CDRH performance standards are certified to comply with the standard by their respective manufacturers. Risk Analysis was performed on the entire system.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
EMC/electrical safety was evaluated according to the IEC Standards. Allengers certify conformance to Voluntary Standards covering Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
Safety Information:
- · The Allengers Medical Systems Limited systems comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31.
- · The Allengers Medical Systems Limited systems comply with the international safety standards:
- o IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012
- o IEC 60601-1-2:2014
- IEC 60601-1-3:2008+A1:2013 o
- IEC 60601-2-54:2009+A1:2015 o
- EN ISO 14971:2012 o
- IEC 62366-1:2015 o
- IEC 62304:2006+AMD1:2015 o
Performance Testing:
Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission. All functions met the design requirements and the image performance criteria satisfactorily.
Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system.
11.Substantial Equivalence Conclusion:
The Allengers Medical Systems Limited systems do not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The operating environment and mechanical design is similar. Allengers Medical Systems Limited considers the DigiX FDX diagnostic X-Ray systems to be substantially equivalent with the predicate devices (K162529 & K081722) with respect to safety and effectiveness.
§ 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.