(264 days)
Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.
Modus IR is an accessory of the Synaptive surgical exoscope. Modus IR provides surgical staff with a means to visualize vessels and blood flow during surgical procedures that may not be visible under white light conditions. When used with the appropriate imaging agent, light output at a specific wavelength excites the imaging agent, which emits light at a specific wavelength that is detected by the optical system, thereby allowing the user to differentiate the structure that the imaging agent has concentrated in. The imaging agent is not packaged or sold as part of Modus IR. It is the responsibility of the user to source and administer the applicable imaging agent according to the excitation and observation wavelengths of Modus IR. Modus IR is selectively enabled by authorized personnel using software configuration management.
Here's a breakdown of the acceptance criteria and study information for the Modus IR device based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Acceptance/Pass Status | Reported Device Performance |
|---|---|---|
| Performance Bench Testing: | ||
| Signal-to-noise ratio (Sensitivity) | Pass | Modus IR was found to have a lower limit of detection and limit of quantification than the predicate at comparable working distances. |
| Fluorescence excitation and emissions | Pass | Although the excitation and emission wavelengths of Modus IR and the predicate device are not identical, they are considered equivalent (Modus IR: 748-802nm excitation, 820-1000nm detection; Predicate: 700-780nm excitation, 820-900nm detection). |
| Non-deformed, non-rotated, non-mirrored, and centered video image | Pass | IR images from Modus IR were found to be non-deformed, non-rotated, non-mirrored, and centered relative to the white light image, based on assessment during in-vivo animal study. |
| Spatial resolution | Pass | Modus IR was found to have a higher spatial resolution than the predicate at each working distance and zoom configuration, including at maximum zoom. |
| Photometric resolution | Pass | Photometric resolution was found to be equivalent between Modus IR and the predicate. |
| Latency to external monitor | Pass | Average latency of Modus IR was found to be lower than the predicate device. |
| In vivo Animal Study: | ||
| Functionally equivalent visualization of intraoperative blood flow and vessel architecture | 100% confirmation | In all 40 comparative evaluations by 10 neurosurgeons, intraoperative blood flow and vessel architecture visualization was found to be functionally equivalent between Modus IR and the predicate device. |
| Suitability of IR Fusion video clips for visualization of intraoperative blood flow against background anatomical structures | 100% confirmation | All IR Fusion video clips from Modus IR were found to be suitable for this purpose. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 4 comparative video sets, resulting in 40 comparative evaluations (4 video sets * 10 neurosurgeons).
- Data Provenance: Prospective, in vivo animal study using two healthy porcine models. The specific country of origin is not mentioned, but the sponsor is based in Canada.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- Number of Experts: 10 neurosurgeons.
- Qualifications of Experts: The document explicitly states "neurosurgeons," implying they are medical professionals specialized in neurosurgery, making them qualified to assess the visualization of cerebrovasculature. Their specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- The study used an assessment by 10 neurosurgeons who were blinded to which system they were evaluating. The video sets were presented in a randomized order.
- The results state "In all evaluations... was found to be functionally equivalent... (100% confirmation)." This implies a consensus or unanimous agreement among the neurosurgeons regarding the functional equivalence and suitability. It doesn't explicitly state a 2+1 or 3+1 method, but the 100% confirmation suggests that all 10 neurosurgeons agreed on the equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Yes, an MRMC-like study was done. The in vivo animal study involved multiple readers (10 neurosurgeons) assessing multiple cases (4 comparative video sets) for comparative effectiveness between the subject device and the predicate.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: This information is not provided in the document. The study aimed to demonstrate functional equivalence between the new device (Modus IR) and a predicate device (INFRARED 800 with FLOW 800 option) for aiding human visualization, not to quantify the improvement of human readers with AI assistance compared to without. Modus IR is an imaging accessory, not an AI-powered diagnostic tool in the sense of AI-driven image analysis or decision support for the clinician.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone algorithm-only performance study was not explicitly mentioned or performed. The Modus IR is an imaging accessory that aids human visualization, not an algorithm that performs a task without human interpretation. Its performance is assessed in the context of aiding a human surgeon.
7. Type of Ground Truth Used
- For the in vivo animal study, the ground truth was expert consensus (10 neurosurgeons' unanimous agreement on functional equivalence and suitability of visualization).
- For the bench tests, the ground truth was based on objective measurements and comparisons against the predicate device using established metrics (e.g., limit of detection, spatial resolution measurements, qualitative assessment for image integrity).
8. Sample Size for the Training Set
- The document does not refer to or describe a training set for the Modus IR in the context of an AI/ML algorithm. Modus IR is described as an optical imaging accessory, not a software algorithm that performs diagnostic or analytical functions requiring a training set for machine learning. The software verification and validation mentioned are typically for ensuring software functions as intended, not for training a model.
9. How Ground Truth for the Training Set Was Established
- As no training set is described for an AI/ML algorithm, this information is not applicable.
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March 25, 2024
Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Synaptive Medical Inc. Tahmina Afzali Senior Regulatory Affairs Specialist 555 Richmond St West, Suite 800 Toronto, ON, M5V 3B1 Canada
Re: K231986
Trade/Device Name: Modus IR Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI Dated: February 22, 2024 Received: February 23, 2024
Dear Tahmina Afzali:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Digitally signed by Adam D. Adam D. Pierce -S Date: 2024.03.25 Pierce -S 17:09:27 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
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and Physical Medicine Devices 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) K231986
Device Name Modus IR
Indications for Use (Describe)
Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
The 510(k) Summary for Modus IR is provided below in accordance with 21 CFR 807.92.
I. Submitter
| Applicant Name: | Synaptive Medical Inc. |
|---|---|
| Address: | 555 Richmond St West, Suite 800Toronto ONCanada M5V 3B1 |
| Applicant Contact: | Tahmina Afzali |
| Contact Telephone: | 647-925-3435 |
| Contact Email: | tahmina.afzali@synaptivemedical.com |
| Secondary Contact: | Matthis HamySenior Manager, Regulatory Affairs647-243-3333Matthis.hamy@synaptivemedical.com |
| Date Prepared | March 18, 2024 |
II. Device Name
| Device Trade Name: | Modus IR |
|---|---|
| Common Name: | Angiographic x-ray system |
| Classification Name: | System, X-Ray, Angiographic |
| Regulation Number: | 21 CFR 892.1600 |
| Regulatory Class: | II |
| Product Code: | IZI |
Legally Marketed Predicate Device III.
Predicate Device: INFRARED 800 with FLOW 800 option
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| 510(k) Number | K100468 |
|---|---|
| Classification Name: | System, X-Ray, Angiographic |
| Regulation Number: | 21 CFR 892.1600 |
| Regulatory Class: | II |
| Product Code: | IZI |
IV. Device Description Summary
Modus IR is an accessory of the Synaptive surgical exoscope. Modus IR provides surgical staff with a means to visualize vessels and blood flow during surgical procedures that may not be visible under white light conditions. When used with the appropriate imaging agent, light output at a specific wavelength excites the imaging agent, which emits light at a specific wavelength that is detected by the optical system, thereby allowing the user to differentiate the structure that the imaging agent has concentrated in. The imaging agent is not packaged or sold as part of Modus IR. It is the responsibility of the user to source and administer the applicable imaging agent according to the excitation and observation wavelengths of Modus IR. Modus IR is selectively enabled by authorized personnel using software configuration management.
V. Indication for Use
Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macrovasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.
VI. Comparison of Technological Characteristics with the Predicate Device
Modus IR is substantially equivalent to INFRARED 800 with FLOW 800 option. Modus IR shares the same fundamental technology characteristics, including principles of operation and mechanism of action as the predicate device, as shown in the Table 1 below. In both devices, the patient is exposed to the light emitted from the light source to illuminate the surgical field as part of intended operation, and visualization of a real time image is provided. For Modus IR, the video feed from the CMOS cameras are exclusively displayed on a primary monitor and optionally a second monitor. For the predicate device, CCD cameras are utilized as sensors and video and images are presented on a monitor. Modus IR provides greater optical zoom and the addition of digital zoom capabilities compared to the predicate device.
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Modus IR and the predicate devices produce light to illuminate the same fluorescence agent Indocyanine Green (ICG) and visualize the emitted fluorescent signal from the distribution of the fluorescence agent in the patient's blood vessels during the operation. Modus IR and INFRARED 800 with FLOW 800 have slightly different excitation and detection wavelength ranges. However, both devices excite Indocyanine Green (ICG) before its peak absorption at 805 nm, with Modus IR's excitation range (748 - 802 nm) being closer to the peak compared to the predicate's excitation range (700 - 780 nm). They also detect emissions in nearly identical ranges (820 - 1000 nm for Modus IR and 820 - 900 nm for the predicate), with Modus IR having a slightly higher upper limit. Overall, Modus IR's excitation and emission wavelengths fall within the specifications of the fluorophore.
| Table 1. Subject and Predicate Devices Technological Characteristics | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Carl Zeiss | Synaptive Medical Inc. | |
| INFRARED 800 with the FLOW 800 option | Modus IR | |
| Basic Function | INFRARED 800 with the FLOW 800 option is an accessory to the OPMI Pentero surgical microscope for visualizing blood flow intraoperatively. FLOW 800 provides the surgeon with a processing mode that allows convenient handling and visualization of the INFRARED 800 video data. | Modus IR is an accessory to the Synaptive surgical exoscope for visualizing vessels and blood flow during surgical procedures. |
| Indication for Use | The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with the FLOW 800 option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastic and reconstructive procedures and coronary artery bypass graft surgery. | Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries. |
| Predicate Device | Subject Device | |
| Carl Zeiss | Synaptive Medical Inc. | |
| INFRARED 800 with the FLOW 800option | Modus IR | |
| Energy usedand/or delivered | The patient is exposed to the light emittedfrom the light source to illuminate thesurgical field, as part of intended operation. | The patient is exposed to the lightemitted from the light source toilluminate the surgical field as part ofintended operation. |
| Sensor | CCD video camera. Infrared- sensitive videocamera, black & white camera.Standard Definition resolution (720 x 480) | CMOS video camera with sensors forwhite light and InfraredHigh-Definition resolution (1920 x1080) |
| FluorescenceAgent | Indocyanine Green (ICG) | Indocyanine Green (ICG) |
| Activation ofFluorescentoption | The press of a single configured fluorescencebutton on the surgical microscope activatesthe fluorescence function | Configuration management enables thefluorescence visualization accessory.Once enabled, the press of a singlebutton on the user interface activatesthe fluorescence function. |
| Visualization ofReal-timeimages | Yes | Yes |
| Display | Video and images are presented on monitor.Picture-in-picture available. | Video feed from surgical camera isdisplayed on a primary surgeon monitorand optionally a second monitor.Picture-in-picture available. |
| Termination ofthe fluorescenceoption | Determined by surgeon or will turn offautomatically after 5 minutes. | Determined by surgeon by turningon/off of the fluorescence option. |
| Light Source | 2x 300W Xenon lamps | 5 LEDs with combined power of5500 mW |
| White LightApplication | 400 - 700 nm | 400 – 700 nm |
| FluorescenceExcitation/Detectionwavelength range | 700 - 780 nm / 820 - 900 nm | 748 - 802 nm / 820 - 1000 nm |
| Distance ofImaging Head toPatient | 200 – 500 mm | 300 - 650 mm |
| CameraAdaptation | Integrated into the microscope head | Integrated into the microscope head |
| Zoom | Motorized 6:1 | Motorized (optical) 7:1Digital up to 12:1 |
| Autofocus | Yes | Yes |
| Control System | Personal Computer | Personal Computer |
| Storage | HDD, DVD | SSD |
| Predicate DeviceCarl ZeissINFRARED 800 with the FLOW 800option | Subject DeviceSynaptive Medical Inc.Modus IR | |
| Biocompatibility | No direct contact with the patient. | No direct contact with the patient. |
Table 1. Subiect and Predicate Devices Technological Characteristics
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VII. Tests Summary
Sterilization and Shelf Life
The device is provided non-sterile. Shelf-Life is not applicable.
Biocompatibility
The device does not have patient-contacting materials; therefore, a biocompatibility assessment is not needed.
Verification and Validation Testing
Software
Software verification and validation testing was conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Device Software Functions" to demonstrate that the software performs as intended and meets user needs.
Performance Bench Testing
Non-clinical verification and validation tests were performed with regards to the intended use, technical claims, requirement specifications and risk management results. Functional and system level testing demonstrated that the device meets the defined specifications.
The following performance bench tests and evaluations were conducted for Modus IR as comparison tests to the predicate device in support of the substantial equivalence determination and to ensure that the clinically relevant parameters for the Indications for Use of Modus IR are fulfilled:
| Test | Test Method Summary | Results |
|---|---|---|
| Signal-to-noiseratio (Sensitivity) | Imaging of an ICG-equivalent concentration sensitivitytarget was conducted with both Subject and Predicatedevices. The sensitivity of Modus IR and the predicate wasmeasured across a range of working distances and at themaximum zoom where the full target is visible. At eachworking distance and zoom, the limit of detection and thelimit of quantification were calculated. The values werethen compared between the two devices. | Pass – Modus IR wasfound to have lowerlimit of detection andlimit of quantificationthan the predicate atcomparable workingdistances. |
Table 2. Performance Bench Testing Summary
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| Test | Test Method Summary | Results |
|---|---|---|
| Fluorescenceexcitation andemissions | Review of excitation and emission wavelengths used byModus IR to excite and detect indocyanine green (ICG)were compared to those used by the predicate device. | Pass – Although theexcitation andemissions wavelengthsof Modus IR and thepredicate are notidentical, they areconsidered equivalent. |
| Non-deformed,non-rotated, non-mirrored, andcentered videoimage | Review of data gathered during the in-vivo animal studywhere Modus IR and the predicate were directly compared.A white light screenshot taken from each system wascompared to a freeze frame from an IR video clip recordedon the system after the screenshot was taken. The infraredimage was qualitatively assessed. | Pass – IR images fromModus IR were foundto be non-deformed,non rotated, non-mirrored and centeredrelative to the whitelight image. |
| Spatial resolution | Imaging of a resolution target made of ICG-equivalentmaterial that fluoresces in the NIR spectrum was conductedwith both Modus IR and predicate device. The horizontaland vertical spatial resolution of each system was measuredacross a range of working distances and zooms. The valueswere then compared between equivalent working distancesand zooms of the two devices. | Pass – Modus IR wasfound to have a higherspatial resolution thanthe predicate at eachworking distance andzoom configuration,including at maximumzoom. |
| Photometricresolution | Quantization of the noise and number of levels availableper pixel (as determined by the bit-depth) were comparedbetween Modus IR and the predicate device. | Pass – Photometricresolution was found tobe equivalent betweenModus IR and thepredicate. |
| Latency to externalmonitor | For both Modus IR and the predicate device, image latencyto the same external monitor was measured and compared. | Pass – Average latencyof Modus IR was foundto be lower than thepredicate. |
In all performance bench tests and evaluations, Modus IR was found to perform as well or better than the predicate device. Based on these results, the images produced by Modus IR were equivalent to, or better than, those of the predicate device.
In vivo Animal Testing
An in vivo animal study was conducted in compliance with 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) to confirm that Modus IR enables viewing of intraoperative blood flow and vessel architecture in a manner that is functionally equivalent to the predicate device INFRARED 800.
The study involved performing a cortical exposure in two healthy porcine models and capturing in vivo video clips of ICG flowing through vasculature using both the subject and predicate devices.
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Four comparative video sets were obtained and assessed by 10 neurosurgeons for equivalence, resulting in 40 comparative evaluations. The neurosurgeons were blinded to which system they were evaluating, and the video sets were presented to them in a randomized order and in a clinically equivalent setup on an external monitor as recommended by the user manuals for both the subject and predicate devices.
Results: In all evaluations, intraoperative blood flow and vessel architecture visualization was found to be functionally equivalent between Modus IR and INFRARED 800 (100% confirmation). Additionally, all IR Fusion video clips from Modus IR were found to be suitable for the visualization of intraoperative blood flow against background anatomical structures (100% confirmation).
The in vivo animal testing confirmed that Modus IR meets its intended use and provides functionally equivalent visualization of intraoperative blood flow and vessel architecture when compared to the predicate device.
VIII. Conclusion
The intended use for Modus IR is similar to the intended use of the predicate device, INFRARED 800 with FLOW 800 option. The technological characteristics of the subject device are similar to those of the predicate device, and the differences have been validated and do not raise any new questions of safety and effectiveness. Results of the verification testing, comparative performance bench testing and in vivo animal study demonstrated that Modus IR is as safe and effective and performs as well as the predicate device. Therefore, Modus IR is substantially equivalent to the predicate, INFRARED 800 with FLOW 800 option.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.