(28 days)
No
The document does not mention AI, ML, deep learning, or any related terms. The "computer vision positioning system" is described as a method for aligning the emitter and cassette, which is a common application of computer vision but doesn't necessarily imply AI/ML for image interpretation or diagnosis. The image processing capabilities mentioned are standard adjustments (brightness, contrast, sharpness) and manipulation (drag, zoom, rotate).
No
The device is described as an X-ray system for taking diagnostic radiographic exposures, indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities." The "Device Description" also mentions its design to "aid clinicians with point of care visualization through diagnostic X-rays of distal extremities."
No
The device description explicitly states it consists of three major hardware subsystems: The Emitter, Cassette, and Control Unit, and is a handheld X-ray system.
Based on the provided information, the Micro C Medical Imaging System, M01 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Micro C Medical Imaging System, M01 is an X-ray system. It uses radiation to create images of the internal structures of the body (specifically extremities in this case). It does not perform tests on biological samples.
- Intended Use: The intended use is for taking diagnostic radiographic exposures of extremities, which is a form of medical imaging, not in vitro testing.
Therefore, the device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IZL
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 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.
Mentions image processing
User Interface can be used to drag, zoom, rotate and also adjust brightness, contrast, and sharpness.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Extremities
Indicated Patient Age Range
Adults
Intended User / Care Setting
Qualified/trained clinicians in a clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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), 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
Additional Non-Clinical performance testing conducted includes:
- Various Functional Testing
- Image Quality Study
- Usability Testing
- Cleaning Study
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
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.(b)
Classification. Class II.
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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)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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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
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
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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.