Who is the manufacturer of Micro C Medical Imaging System, M01?

Oxos Medical, Inc. filed the 510(k) submission for Micro C Medical Imaging System, M01 (K203658).

What is the FDA product code for Micro C Medical Imaging System, M01?

IZL. It is classified under 21 CFR 892.1720 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Micro C Medical Imaging System, M01?

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

Who can help prepare an FDA 510(k) submission like Micro C Medical Imaging System, M01?

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.

Micro C Medical Imaging System, M01

Q: What are the predicate devices for Micro C Medical Imaging System, M01?

Nomad MD 75kV Handheld X-Ray System (K140723).

K203658 · Oxos Medical, Inc. · IZL · Jan 12, 2021 · Radiology

Device Facts

Record ID	K203658
Device Name	Micro C Medical Imaging System, M01
Applicant	Oxos Medical, Inc.
Product Code	IZL · Radiology
Decision Date	Jan 12, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1720
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

The M01 System is a hand-held X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of extremities.

Device Story

Handheld, portable X-ray system for point-of-care diagnostic imaging of extremities; used by clinicians in clinical environments. System comprises three subsystems: Emitter (X-ray tube, operator control panel, computer vision camera), Cassette (X-ray detector, IR/status lights for positioning), and Control Unit (high voltage generator, computing, monitor/keyboard interface). Operator positions emitter over patient anatomy using computer vision guidance; cassette collects X-ray energy, converting it to digital representation. System produces static and serial radiographic images; supports DICOM 3.0 for PACS transfer. Benefits include portable, point-of-care visualization for extremity diagnostics.

Clinical Evidence

Bench testing only. Evidence includes functional testing, image quality study, usability testing, and cleaning study. Compliance with IEC 60601 series (safety/performance), ISO 14971 (risk management), ISO 10993-1 (biocompatibility), and 21 CFR 1020.30/31 (radiation safety) demonstrated.

Technological Characteristics

Handheld X-ray system; 120 VAC power. Detector: Cesium Iodide (CsI) scintillator, 99 μm pixel size, 70% DQE @ 0Lp/mm. Connectivity: WiFi, Ethernet, USB 2.0. Software: Custom validated, DICOM 3.0 compliant. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-2-28, IEC 62304, ISO 14971, ISO 10993-1.

Indications for Use

Indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. Not intended to replace radiographic systems with variable tube current and voltage (kVp) required for full optimization of image quality and radiation exposure.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Nomad MD 75kV Handheld X-Ray System (K140723)

Reference Devices

KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography (K193225)
KDR™ AU System Advanced U-Arm with Static Digital Radiography (K193225)
Faxitron VisionCT (K173309)

Related Devices

K211473 — Micro C Medical Imaging System, M01 · Oxos Medical, Inc. · Jun 4, 2021
K193535 — EZER, Portable X-ray System · Livermoretech, Inc. · May 7, 2020
K212654 — Micro C Medical Imaging System, M01 · Oxos Medical, Inc. · Feb 4, 2022
K252068 — MC2 Portable X-ray System · Oxos Medical · Dec 22, 2025
K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS · Prognosys Medical Systems Private Limited · Jul 29, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. January 12, 2021 % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL, MINNESOTA 55114 Re: K203658 Trade/Device Name: Micro C Medical Imaging System, M01 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: December 14, 2020 Received: December 15, 2020 Dear Prithul Bom: 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use # 510(k) Number (if known) Unknown K203658 Device Name Micro C Medical Imaging System, M01 #### Indications for Use (Describe) The Micro C Medical Imaging System. M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CER 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CER 801 Subpart C) </div> | ### 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." {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for OXOS Medical. The logo consists of four symbols: a circle with two gaps, an X, a circle with two gaps, and an S. Below the symbols, the word "MEDICAL" is written in a sans-serif font. # Section 5 510(k) Summary K203658 In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Micro C Medical Imaging System, M01 Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005. | Submitter: | OXOS Medical, Inc 1230 Peachtree St NE Suite Suite #300 Atlanta, GA 30309 Tel: 1-800-SEE-XRAY | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission Contact: | Mo Khosravanipour Director of Program Management OXOS Medical, Inc. Email: Mo@oxos.com | | | Grace Powers, MS, MBA, RAC | | | Founder/Principal Consultant | | | Powers Regulatory Consulting | | | Email: grace@powersregulatory.com | | Submission Date: | November 16, 2019 | | Subject Device: | Trade Name: Micro C Medical Imaging System, M01 Common Name: Mobile X-Ray System | | | Regulation: 21 CFR § 892.1720 | | | Regulatory Classification: 2 | | | Product Code: IZL | | | Classification Panel: Radiology | | Predicate Device: | Legally marketed device to which substantial equivalence is claimed: Nomad MD 75kV Handheld X-Ray System (K140723) | | Reference Devices: | KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography (K193225) Faxitron VisionCT (K173309) | ### Device Description: The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C {4}------------------------------------------------ ### Section 5 510(k) Summary Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment. A description of the three major sub-systems is listed below. - Emitter: This component contains the operator control panel, X-ray tube, and computer vision camera. The control panel allows the operator to control the major functions of the device, including the technique factors. This component is controlled and held in the operator's hand. - Cassette: This component contains the X-ray detector that collects the X-ray energy and provides a digital representation to the control unit for eventual display. This component also contains status lights and IR lights to assist in X-ray field positioning. The patient anatomy of interest is placed on top of this module. - Control Unit: This component contains the High Voltage generator, computing power, monitor and keyboard inputs, and other electronics required for the functioning of the device. This module is typically placed on a shelf, cart, counter, or other flat surface convenient to the operator and environment. The system is intended to work in conjunction with a DICOM monitor, keyboard and a mouse and the mains power outlet. The Micro C Medical Imaging System, M01 has custom validated software that includes a user interface that allows the operator to view and adjust captured radiographs, and transfer radiographs to a PACS server or flash drive. Image /page/4/Picture/8 description: The image shows a white box connected to a white device with two cables. The white box has several ports on its side, and two cables are plugged into it. One cable is light blue and the other is gray. The light blue cable connects the box to a white device, and the gray cable connects the box to a different port on the white device. # Figure 5-1: Subject Device - Micro C Medical Imaging System, M01 {5}------------------------------------------------ Image /page/5/Figure/2 description: The image shows a computer setup with a monitor, keyboard, and mouse connected to a device. The monitor is connected to the device via a cable, and the keyboard and mouse are also connected to the device. The device is connected to a power outlet via a power cord. The image shows the connections between the different components of the computer setup. ### Intended Use: The M01 System is a hand-held X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of extremities. ### Indications for Use: The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types. ### Technological Characteristics The Micro C Medical Imaging System, M01 has similar technological characteristics as the predicate device, Nomad MD 75kV Handheld X-Ray System cleared via K140723. The Micro C Medical Imaging System, M01 also includes a detector. The detector is identical to the Faxitron VisionCT (K173309). The Micro C Medical Imaging System, M01 also includes serial radiography similar to the reference device KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography cleared via K193225. The table below compares the subject, predicate and reference device. A comparison of the detectors is in the second table below. | | Subject Device: Micro C Medical Imaging System, M01 | Predicate Device: Nomad MD 75kV Handheld X-Ray System K140723 | Reference Device: KDRTM AU-DDR System Advanced U-Arm K193225 | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | IZL (Mobile X-Ray System) | IZL (Mobile X-Ray System) | KPR (System, X-Ray, Stationary), MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager) | | Regulation | 21 CFR 892.1720 | 21 CFR 892.1720 | 21 CFR 892.1680 | | Classification Name | Mobile X-Ray System | Mobile X-Ray System | Stationary X-ray System | | Classification | Class 2 | Class 2 | Class 2 | | Indication for Use | The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types. | The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types. | The KDRTM AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDRTM AU System Advanced U-Arm with Static Digital Radiography is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography). | | Age of Device Use | Adults | Adults and Children | Adults and Children | | Principle of Operation | General purpose diagnostic X-ray | General purpose diagnostic X-ray | General purpose diagnostic X- ray | | Image type produced | Static, serial radiographic and photographic images for convenience. | Static images only | Static or serial radiographic images | | Detector | 6 x 6" digital detector | No detector provided. | 16.7 x 16.7" digital detector | | Collimator | The removable fixed collimators (referred to as pucks) | Four manually and steplessly adjustable shutters with LED Light Field Center Indicator to limit the X-ray. | Six pairs of motorized automatic collimation with manual override possible, light field Indicator and two Lasers and Camera. | | Weight | Emitter: 2.86kg (6.3lbs) Cassette: 6.5kg (14.3lbs) Control Unit: 8.6kg (19.0lbs) | 11.0lbs | Stationary device | | Dimension/ Size | Emitter: 9.3"H x 3.5"W x 8.3"L (excluding SSD Cone) Cassette: 15.5"H x 15.5"W x 2.8"L | 9.5"H x 5.25"W x 10"L (excluding Source Skin guard) | Stationary device with U- Mount arm and X-ray table | | Control Unit: 16.4"H x 12.9"W x 5.5"L | | | | | Triggering Mechanism | Two stage triggering | Two stage triggering | Start button on the user interface after set up. | | Minimum Source to skin distance (SSD) | 20 cm SSD Cone ensures minimum SSD of 20 cm | 30 cm Source Skin Guard ensures minimum SSD of 30 cm | Unknown | | Source to Detector distance | 20 - 45 cm | Not limited | 100 - 200 cm | | Light Field | Virtual light field on Monitor UI. No projected light field. | Projected light field | Projected light field | | Energy Source | 120 VAC / 60 Hz (no rechargeable battery) | Rechargeable 14.4V DC NiCd battery pack (also contains an AC to DC power supply) | 480 VAC/ 60Hz (generator) | | Exposure Time | 33ms, 66ms and 99ms | 20 – 990ms in 10ms increments | 1-1000 ms in various increments | | mA | 1.0 mA fixed | 2.0 mA fixed | 100-1000 mA in various increments | | kVp | 40kVp, 50kVp, and 60kVp | 75 kVp fixed | 40-150 kVp in various increments | | Ingress Protection Rating | IPOO | IP0; do not operate under wet conditions | Unknown | | Image Processing | User Interface can be used to drag, zoom, rotate and also adjust brightness, contrast, and sharpness. | Not applicable | User interface has optional post-processing functions such as brightness, sharpness, annotations, stitching and other functions. | | Connectivity Options | WiFi, Ethernet, Four USB 2.0 ports | Not applicable | Ethernet, USB ports | | DICOM | Yes- DICOM 3.0 Compliant | Not applicable | Yes- DICOM 3.0 Compliant | | Device Package Contents | Cassette Control Unit Emitter Collimation Pucks SSD Cone Cassette Power Cable Cassette Data Cable Control Unit Power Cable Connector Covers | Nomad MD device Spare Battery Charging Cradle AC-to-DC Power Supply | A floor and wall-mounted Positioner (also referred to as a stand) Generator Off-the-shelf computer with proprietary software (also referred to as an acquisition workstation) | | | Instructions for Use Case | | | ### Table 5-2: Device Comparison {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Section 5 510(k) Summary Faxitron VisionCT cleared under K173309 contains the identical detector (Xineos-1515 manufactured by Teledyne DALSA) as the subject device. The Faxitron VisionCT is a stationary X-ray but is used for specimen radiography. | | Subject Device: Micro C Medical Imaging System, M01 | Reference Device: Faxitron VisionCT (K173309). | Reference Device: KDR TM AU-DDR System Advanced U-Arm K193225 | |---------------------------|-----------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------| | Scintillator | Cesium Iodide (CsI) | Cesium Iodide (CsI) | Cesium Iodide (CsI) | | Resolution/ Pixel size | 99 μm | 99 μm | 100 μm | | DQE @ 0Lp/mm | 70% | 70% | 72% | | MTF @ 1 Lp/mm, RQA5 | 60% | 60% | Unknown | #### Table 5-3: Detector Comparison Note: The predicate device does not have a detector. ### Non-Clinical Performance Data Testing was performed successfully according to the following standards and CFR: - . ISO 14971 Edition 2 2007 Application of risk management to medical devices (FR Recognition number 5-40) - 21 CFR 1020.30 Diagnostic X-ray systems and their major components (met via conformity to IEC 60601-1-3 and 60601-2-54, and 21 CFR 1020.30 parts (a), (b), (d), (e),(g), (j), and (q)) - 21 CFR 1020.31 Radiographic equipment (met via conformity to IEC 60601-1-3 and 60601-2-54) - IEC 60601-1 Edition 3.1 2005 Requirements for Medical Electrical Equipment (FR Recognition number 19-4) - . IEC 60601-1-2 Edition 4 2014 Requirements for Medical Equipment (FR Recognition number 19-8) - IEC 60601-1-3 Edition 2.1 2013 Requirements for Medical Electrical Equipment (FR Recognition number 12-269) - IEC 60601-1-6 Edition 3.1 2013 Requirements for Medical Electrical Equipment, and IEC 62366-1 Edition 1.0 2015 Application of usability engineering to medical devices (FR Recognition number 5-89) - . IEC 60601-2-28 Edition 3.0 2017 Requirements for X-ray Tube Assemblies (FR Recognition number 12-309) - . IEC 60601-2-54 Edition 1.1 2015 Requirements for Medical electrical equipment for radiography (FR Recognition number 12-296) - IEC 62304 Edition 1.1 2015 for all software product lifecycle development (FR Recognition number 13-79) - ISO 10993-1 Edition 5 2018 (FR Recognition number 2-258) - 21 CFR 801: Labeling - IEC 60825 Edition 3.0 2014 requirements for Lasers (FR Recognition number 12-273) - DICOM Standard when interfacing with PACS {9}------------------------------------------------ Additional Non-Clinical performance testing conducted includes: - Various Functional Testing - Image Quality Study ● - Usability Testing - Cleaning Study The following specific guidance document was utilized in the device development to ensure the safety of this device for both the operators and patients: - Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards - Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - . Radiation Safety Considerations for X-ray Equipment Designed for Hand-held Use #### Conclusion The Micro C Medical Imaging System, M01 is similar to the legally marketed predicate device as demonstrated by the same intended use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.