← Product Code [DQK](/productcode/DQK) · K253473 # Synchrony (K253473) _Stereotaxis, Inc. · DQK · Apr 1, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253473 ## Device Facts - **Applicant:** Stereotaxis, Inc. - **Product Code:** [DQK](/productcode/DQK.md) - **Decision Date:** Apr 1, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1425 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Stereotaxis Synchrony™ system is an optional display and user interface package designed to consolidate the point of control of a medical lab. ## Device Story Synchrony is a display and user interface package for catheter laboratories; consolidates multiple lab display outputs onto a single screen; integrates control of multiple lab input devices via single keyboard and mouse. Used by clinicians to customize layouts, simplify interfaces, and streamline clinical workflows. Operates as a centralized control hub for diagnostic tools within the lab environment. Benefits include improved workflow efficiency and reduced complexity in managing multiple lab systems. ## Clinical Evidence Bench testing only. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), functional performance, and cybersecurity penetration tests. No clinical data presented. ## Technological Characteristics Display monitor and user interface package; consolidates video/input signals. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). Risk management per ISO 14971. Connectivity involves system communication for video transfer and input device integration. ## Regulatory Identification A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs. ## Predicate Devices - Odyssey ([K093092](/device/K093092.md)) - Odyssey ([K072371](/device/K072371.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 1, 2026 Stereotaxis, Inc. Angela McKnight Senior Regulatory Affairs Specialist 710 Tucker Blvd. Suite 110 Saint Louis, Missouri 63101 Re: K253473 Trade/Device Name: Synchrony Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 10, 2025 Received: October 10, 2025 Dear Angela McKnight: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253473 - Angela McKnight Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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 {2} K253473 - Angela McKnight Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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, MARCO CANNELLA -S for: - Aneesh Deoras - Assistant Director - Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices - Office of Cardiovascular Devices - Office of Product Evaluation and Quality - Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) 253473 | | | Device Name Synchrony | | | Indications for Use (Describe) The Stereotaxis Synchrony™ system is an optional display and user interface package designed to consolidate the point of control of a medical lab. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *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.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} K253473 510(k) Summary [21 CFR 807.92] # Submitter Name and Address: Stereotaxis, Inc. 710 N. Tucker Blvd. Suite 110 St. Louis, MO 63101 Establishment Registration Number: 3003084417 Primary Contact: Angela McKnight Senior Regulatory Affairs Specialist (314) 303-6424 angela.mcknight@stereotaxis.com Date Prepared: October 10, 2025 # Device Information Device Name: Synchrony Classification/ Common Name: Programmable diagnostic computer Classification: II Product Code: DQK Regulation Number & Name: 21 CFR 870.1425 Classification Panel: Cardiovascular # Predicate Information | | 510(k) Number | Trade Name | Product Class | Product Code | | --- | --- | --- | --- | --- | | Primary Predicate | K093092 | Odyssey | II | DQK | | Secondary Predicate | K072371 | Odyssey | II | DXX | K253473 Stereotaxis Traditional 510(k) Notification {5} # Device Description The primary objective of Synchrony is to allow the clinician to customize layouts to address their needs which permit them to: 1. Consolidate the output multiple catheter laboratory displays on a single screen 2. Consolidate the control of multiple lab input devices with a single keyboard and mouse 3. Simplify the user interface 4. Streamline clinical workflows # Intended Use / Indications for Use The Indications for Use / Intended Use are provided below: - The Stereotaxis Synchrony system is an optional display and user interface package designed to consolidate the point of control of a medical lab. # Substantial Equivalence Synchrony has the same intended use as and is substantially equivalent in design and functionality to Odyssey (K072371, cleared November 14, 2007) and Odyssey (K093092, cleared January 21, 2010). Synchrony and Odyssey are designed with a display monitor and user interface package that allows the clinician to view multiple diagnostic tool screens. The main differences of Synchrony relative to Odyssey are the image processing, video transfer and system communication. Design verification and validation testing of Synchrony was conducted to show substantial equivalence to the predicate device. Testing conducted was identified on the basis of risk analysis activities performed to evaluate the impact of the modification on the device. Testing activities included electrical safety, functional performance and cybersecurity penetration tests. Risk analysis activities were completed based on ISO 14971. Electrical/mechanical device safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1 and 60601-1-2. The modifications do not introduce or raise different questions about the safety or effectiveness of the device. # Performance Data The determination of substantial equivalence for this device was based on a detailed device description and bench testing. Test results demonstrate that Synchrony meets specifications and performs as intended. No new safety or performance issues were raised during testing. Synchrony is substantially equivalent to the predicate devices. # Conclusion K253473 Stereotaxis Traditional 510(k) Notification Page 2 {6} Based upon the documentation presented in this 510(k) it has been demonstrated that Synchrony is safe and effective for its intended use and Synchrony is substantially equivalent to the predicate devices Odyssey (K072371) and Odyssey (K093092). K253473 Stereotaxis Traditional 510(k) Notification Page 3 --- **Source:** [https://fda.innolitics.com/device/K253473](https://fda.innolitics.com/device/K253473) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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