Who is the manufacturer of Cardiovascular Angiography System?

Allengers Medical Systems Limited filed the 510(k) submission for Cardiovascular Angiography System (K220311).

What is the FDA product code for Cardiovascular Angiography System?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Cardiovascular Angiography System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cardiovascular Angiography System?

Allura Xper FD Series and Allura Xper OR Table serie (K162859).

Who can help prepare an FDA 510(k) submission like Cardiovascular Angiography System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cardiovascular Angiography System

K220311 · Allengers Medical Systems Limited · OWB · May 3, 2022 · Radiology

Device Facts

Record ID	K220311
Device Name	Cardiovascular Angiography System
Applicant	Allengers Medical Systems Limited
Product Code	OWB · Radiology
Decision Date	May 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body. Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations. This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance. Exclusion: This system is not recommended for Mammography. Contraindication: Exposure of X-Ray should be avoided during pregnancy.

Device Story

Cardiovascular Angiography System performs fluoroscopic and digital radiographic studies in catheterization labs. System inputs include X-ray pulses generated by high-frequency generators and captured by solid-state X-ray detectors (FPD). The system transforms these inputs into digital images for visualization of vascular structures. Operated by trained clinicians, the system includes a C-arm (floor, ceiling, or mobile), patient table, and ceiling-suspended displays. Output is viewed on monitors to assist in interventional cardiovascular, neurovascular, and pacemaker procedures. The device aids clinical decision-making by providing real-time imaging for diagnostic and interventional guidance, potentially improving patient outcomes through precise visualization of complex anatomical structures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including functional testing of motion systems, imaging performance evaluation, and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, and IEC 60601-2-54 standards.

Technological Characteristics

High-frequency, microprocessor-controlled X-ray generator; rotating anode X-ray tubes; amorphous silicon or CMOS solid-state X-ray detectors; C-arm configuration (floor/ceiling/mobile); DICOM 3.0 connectivity; software-based digital imaging system. Safety compliance per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, and IEC 60601-2-54.

Indications for Use

Indicated for cardiovascular, neurovascular, and interventional procedures, including pacemaker implantation and high-end investigations, in adult and pediatric populations. Contraindicated for mammography and during pregnancy.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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

Allura Xper FD Series and Allura Xper OR Table serie (K162859)

Reference Devices

Ziehm Vision RFD (K203428)
Varex Imaging corporation – Paxscan 2020 DXV (K200218)
Varex Imaging corporation – Paxscan 3030 DXV (K200218)
MX Imaging - CFP 2222 (K171755)
MX Imaging - CFP 3131 (K171755)
Thales Group – Pixium Surgical 2121S-A (K183040)
Thales Group - Pixium 2121S-AU (K200218)
Thales Group - Pixium Surgical 3030S-A (K172822)
Thales Group - Pixium 3030S-AU (K200218)
IRAY Technology - Mercu 0909F (K200218)

Related Devices

K031333 — PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 · Philips Medical Systems North America, Inc. · May 13, 2003
K082830 — INFX-8000H, INFINIX-I · Toshiba America Medical Systems, In.C · Oct 10, 2008
K024200 — INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) · Ge Medical Systems, Inc. · Jan 16, 2003
K022899 — PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 · Philips Medical Systems North America Co. · Nov 22, 2002
K964990 — HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) · Hitachi Medical Systems America, Inc. · Feb 26, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 3, 2022 Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall Unit-2, Bhankarpur, Mubarakpur Road, Derabassi. Distt. Mohali, Punjab 140507 INDIA Re: K220311 Trade/Device Name: Cardiovascular Angiography System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: January 27, 2022 Received: February 2, 2022 Dear 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 {1}------------------------------------------------ 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 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 (OS) 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, Laurel Burk Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K220311 Device Name Cardiovascular Angiography System #### Indications for Use (Describe) The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body. Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations. This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance. Exclusion: This system is not recommended for Mammography. Contraindication: Exposure of X-Ray should be avoided during pregnancy. Type of Use (Select one or both, as applicable) 7 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. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov "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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ ### 510(k) SUMMARY This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92. ### 1. Contact Person and Address | Company Name: | Allengers Medical Systems Limited | |------------------|-----------------------------------------------------------------------------------------| | Company Address: | FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi, Distt Mohali-140507, India | | Telephone No: | +91 1762-282600 +919872980168 rnd@allengers.net | | Contact Person: | Sanjeev K. Marjara | | Date Prepared: | 27.01.2022 | ### 2. Proposed Device: | Device (trade) name: | Cardiovascular Angiography System | | | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Model Name: | Proxima FDX, Altima FDX Adv Digiscan FDX-V8043, Digiscan FDX-V8030, Digiscan FDX-V8020 Digiscan FDX-V6543, Digiscan FDX-V6530, Digiscan FDX-V6520 Digiscan FDX-V4043, Digiscan FDX-V4030, Digiscan FDX-V4020 Digiscan FDX-V2743, Digiscan FDX-V2730, Digiscan FDX-V2720 | | | | Classification Name : | Image-Intensified Fluoroscopic X-Ray System | | | | Classification Panel: | Radiology | | | | Regulation Number : | 21 CFR 892.1650 | | | | Device Class: | Class II | | | | Product Code: | Primary Code : OWB Subsequent Code : JAA and OXO for 'Digiscan FDX-VXXYY | | | ### 3. Predicate Device: | Device (trade) name: | Allura Xper FD Series and Allura Xper OR Table serie | | |-----------------------|------------------------------------------------------|--| | 510(K) Number: | K162859 | | | Clearance Date: | December 2, 2016 | | | Classification Name: | Image-Intensified Fluoroscopic X-Ray System, | | | Classification Panel: | Radiology | | | Regulation Number: | 21 CFR 892.1650 | | | Device Class: | Class II | | | Product Code: | Primary Code : OWB Subsequent Code : JAA | | ¹ Where XX may be 80/65/40/27 and YY may be 43/30/20 {4}------------------------------------------------ ### 4. Reference devices: | Device (trade) name: | Ziehim Vision RFD | |-----------------------|--------------------------------------------------| | 510(K) Number: | K203428 | | Clearance Date: | March 17, 2021 | | Classification Name: | Image-Intensified Fluoroscopic X-Ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR 892.1650 | | Device Class: | Class II | | Product Code: | Primary Code : OWB Subsequent Code : JAA, OXO | Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have been previously cleared by FDA or tested and evaluated per quidance for submission of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state detectors used with device. | Solid State Detectors | 510(K) Numbers | |----------------------------------------------|----------------| | Varex Imaging corporation – Paxscan 2020 DXV | K200218 | | Varex Imaging corporation – Paxscan 3030 DXV | K200218 | | Varex Imaging corporation - Paxscan 4343DXV | -- | | MX Imaging - CFP 2222 | K171755 | | MX Imaging - CFP 3131 | K171755 | | Thales Group – Pixium Surgical 2121S-A | K183040 | | Thales Group - Pixium 2121S-AU | K200218 | | Thales Group - Pixium Surgical 3030S-A | K172822 | | Thales Group - Pixium 3030S-AU | K200218 | | IRAY Technology - Mercu 0909F | K200218 | | Allengers Medical Systems Ltd - FP 2121 RF | -- | | Allengers Medical Systems Ltd - FP 2121 HR | -- | | Allengers Medical Systems Ltd - FP 3030 HR | -- | Table 1 List of Solid State X-Rav Image Detectors ### 5. Device description: The Cardiovascular Angiography system is designed to perform fluoroscopic & digital radiographic studies and are used in interventional examinations. This system covers the complete range of angiographic applications, cardiac angiography, neuroangiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and digital radiographic/ fluoroscopic procedures. The following components are configured to create the Cardiovascular Angiography system: - 1. Floor mounted C-arm (Altima FDX Adv) or Ceiling Mounted C-Arm (Proxima FDX) or Mobile C-Arm (2Digiscan FDX-VXXYY), X-ray tube assembly and Solid State X-Ray image detector - 2. Patient Table - 3. Ceiling suspended display(s) 2 Where XX may be 80/65/40/27 and YY may be 43/30/20 {5}------------------------------------------------ - 4. Footswitch for releasing radiation - 5. Control console for controlling the stand, patient table, collimator and imaging system. 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 | | |-----------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | X-Ray Generator | Allengers | Proxima FDX Altima FDX Adv | XGEN-100CV | | | | Proxima FDX Altima FDX Adv | | | X-Ray Generator | Allengers | Digiscan FDX-V8043 Digiscan FDX-V8030 Digiscan FDX-V8020 | XGEN-80CV | | | | | | | | | | | | X-Ray Generator | Allengers | Digiscan FDX-V6543 Digiscan FDX-V6530 Digiscan FDX-V6520 | XGEN-65CV | | | | | | | | | | | | X-Ray Generator | Allengers | Digiscan FDX-V4043 Digiscan FDX-V4030 Digiscan FDX-V4020 | XGEN-40CV | | | | | | | | | | | | X-Ray Generator | Allengers | Digiscan FDX-V2743 Digiscan FDX-V2730 Digiscan FDX-V2720 | XGEN-27CV | | | | | | | | | | | | X-Ray Tube | Siemens Healthcare GmbH | Proxima FDX Altima FDX Adv | Megalix CAT 125/35/80 125 GW Megalix CAT 125/15/40/80122 GW | | | | | | | | | | | | X-Ray Tube | Canon Electron Tubes and devices | Proxima FDX Altima FDX Adv | E79039X E79030X E79016X | | | | | | | | | | | | X-Ray Tube | Varex Imaging | Proxima FDX Altima FDX Adv Digiscan FDX-V8043 Digiscan FDX-V8030 Digiscan FDX-V8020 Digiscan FDX-V6543 Digiscan FDX-V6530 Digiscan FDX-V6520 Digiscan FDX-V4043 Digiscan FDX-V4030 Digiscan FDX-V4020 | G1082, G-1582BI, G2090, G1092 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | {6}------------------------------------------------ | X-Ray Tube | Varex Imaging | Digiscan FDX-V2743 Digiscan FDX-V2730 Digiscan FDX-V2720 | A-145, RAD-99, RAD-99B, RAD-15 | |------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Solid State X- Ray Image Detectors | Varex Imaging | Proxima FDX Altima FDX Adv Digiscan FDX-V8020 Digiscan FDX-V6520 Digiscan FDX-V4020 Digiscan FDX-V2720 | Paxscan 2020 DXV | | Solid State X- Ray Image Detectors | Varex Imaging | Proxima FDX Altima FDX Adv Digiscan FDX-V8030 Digiscan FDX-V6530 Digiscan FDX-V4030 Digiscan FDX-V2730 | Paxscan 3030 DXV | | Solid State X- Ray Image Detectors | Varex Imaging | Proxima FDX Altima FDX Adv Digiscan FDX-V8043 Digiscan FDX-V6543 Digiscan FDX-V4043 Digiscan FDX-V2743 | Paxscan 4343DXV | | Solid State X- Ray Image Detectors | IRAY Technology | Proxima FDX Altima FDX Adv Digiscan FDX-V8020 Digiscan FDX-V6520 Digiscan FDX-V4020 Digiscan FDX-V2720 | Mercu 0909F | | Solid State X- Ray Image Detectors | Thales Group | Proxima FDX Altima FDX Adv Digiscan FDX-V8020 Digiscan FDX-V6520 Digiscan FDX-V4020 Digiscan FDX-V2720 | Pixium 2121S-AU Pixium Surgical 2121S-A | | Solid State X- Ray Image Detectors | Thales Group | Proxima FDX Altima FDX Adv Digiscan FDX-V8030 Digiscan FDX-V6530 Digiscan FDX-V4030 Digiscan FDX-V2730 | Pixium 3030S-AU Pixium Surgical 3030S-A | | Solid State X- Ray Image Detectors | MX Imaging | Proxima FDX Altima FDX Adv Digiscan FDX-V8020 | CFP 2222 | {7}------------------------------------------------ | Solid State X- Ray Image Detectors | MX Imaging | Digiscan FDX-V6520 Digiscan FDX-V4020 Digiscan FDX-V2720 | | |------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | | | Digiscan FDX-V8030 Digiscan FDX-V6530 Digiscan FDX-V4030 Digiscan FDX-V2730 | CFP 3131 | | Solid State X- Ray Image Detectors | Allengers | Proxima FDX Altima FDX Adv Digiscan FDX-V8020 Digiscan FDX-V6520 Digiscan FDX-V4020 Digiscan FDX-V2720 | FP 2121 RF FP 2121 HR | | | | | | | Solid State X- Ray Image Detectors | Allengers | Proxima FDX Altima FDX Adv Digiscan FDX-V8030 Digiscan FDX-V6530 Digiscan FDX-V4030 Digiscan FDX-V2730 | FP 3030 HR | | | | | | | Patient Table | Allengers | Proxima FDX Altima FDX Adv | C Tab F FDX C Tab FXL FDX C Tab FCV FDX | | Patient Table | Allengers | Digiscan FDX-V8043 Digiscan FDX-V8030 Digiscan FDX-V8020 Digiscan FDX-V6543 Digiscan FDX-V6530 Digiscan FDX-V6520 Digiscan FDX-V4043 Digiscan FDX-V4030 Digiscan FDX-V4020 Digiscan FDX-V2743 Digiscan FDX-V2730 | C Tab M FDX Vascu Tab FDX | {8}------------------------------------------------ #### 6. Indications for Use: The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body. Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations. This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance. Exclusion: This system is not recommended for Mammography. Contraindications: Exposure of X-Ray should be avoided during pregnancy. #### 7. Technological Characteristics Comparison to Predicate & Reference Devices: The Cardiovascular Angiography Systems having set of components similar to the Allura Xper FD Series and Allura Xper OR Table series (K162859) and Ziehm Vision RFD (K203428) as compared in Table 3 found below in this Section. This table below shows that the systems are either similar, or the same, as the predicate & reference device. #### 8. Software Feature Synergy FP FDX & Synergy FDX-CR imaging software is a Digital Imaging System (DIS) provides useful functions to manage X-Ray images obtained from Cardiovascular Anqiography System. The software feature set and functions is essentially the same as the device, with the system complying with DICOM 3.0 specifications .Refer to section 9 Image processing and storage of the table 3 for a list of top level functions #### 9. Substantial Equivalence: The Cardiovascular Angiography system are substantially equivalent to the commercially available Allura Xper FD series and Allura Xper OR Table series (K162859) & Ziehm Vision RFD (K203428). Functional and specification differences are identifying in the following table. {9}------------------------------------------------ | Feature | Cardiovascular Angiography System (Subject Device) | Allura Xper FD Series and Allura Xper OR Table series (Predicate Device) | Ziehm Vision RFD (Reference Device) | Justification for differences | | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | 1. 510(k) | This submission | K162859 | K203428 | | | | 2. Product Code | | | | | | | Product Classification Code | OWB, JAA & OXO for 'Digiscan FDX- VXXYY' | OWB and JAA | OWB , JAA & OXO | Same | | | 3. Product Classification | | | | | | | Classification | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | Same | | | 4. Indication for Use | | | | | | | Indications for Use | The Cardiovascular Angiography system is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body. Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations. This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance. Exclusion: This system is not recommended for Mammography. Contraindications: Exposure of X-Ray should be avoided during pregnancy. | The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: • Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. • Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). • Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: • The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room. • Allura Xper FD10 is compatible with specified magnetic navigation systems. • Combined with a | The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the | Essentially the same Note: There are no differences between the subject device and the predicate with respect to indication and intended use. | | | Feature | Cardiovascular Angiography System (Subject Device) | Allura Xper FD Series and Allura Xper OR Table series (Predicate Device) | Ziehm Vision RFD (Reference Device) | Justification for differences | | | | | qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR. | cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems. | | | | 5. X-Ray Generator | | | | | | | Type | Microprocessor-controlled, high frequency converter generator | Microprocessor-controlled, high frequency converter generator | Monoblock and High Frequency Generator | Same as Predicate device | | | Power Rating | XGEN-100CV | 100KW | 100 KW | 30 KW…