← Product Code [QKB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QKB) · K193252 # Contour ProtegeAI (K193252) _Mim Software, Inc. · QKB · Jul 2, 2020 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QKB/K193252 ## Device Facts - **Applicant:** Mim Software, Inc. - **Product Code:** [QKB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QKB.md) - **Decision Date:** Jul 2, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** AI/ML, Software as a Medical Device ## Intended Use Contour ProtégéAI is used by trained medical professionals as a tool to aid in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. Contour ProtégéAl assists in the following indications: The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. Segmenting normal structures across a variety of CT anatomical locations. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Contour ProtégéAI must be used in conjunction with MIM software to review and, if necessary, edit contours that were automatically generated by Contour ProtégéAI. ## Device Story Contour ProtégéAI is a server-based software accessory to MIM software; it processes DICOM-compliant CT and MR images. It utilizes machine-learning algorithms to automatically generate anatomical contours for radiation therapy planning, adaptive therapy, and quantitative analysis. The device is operated by trained medical professionals (e.g., radiologists, oncologists, physicists). The system is deployed on a remote server using MIMcloud for data management. The healthcare provider reviews and edits the automatically generated contours within the MIM software environment. By automating the initial contouring process, the device aims to reduce the time required for manual segmentation and support clinical workflows. ## Clinical Evidence Bench testing only. Performance evaluated using 286 CT images and 72 MR images from institutions disjoint from the training set. Non-inferiority testing compared mean Dice coefficients of Contour ProtégéAI against the predicate device. Results confirmed non-inferiority with a limit of 0.1 Dice, deemed clinically acceptable. ## Technological Characteristics Server-based software application supporting Linux-based OS. Uses machine-learning algorithms for automated image segmentation. Compatible with ACR/NEMA DICOM 3.0 standards. Deployed via MIMcloud for data management and transfer. Operates on Windows, Mac, and Linux client systems. ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - MIM on Linux ([K190379](/device/K190379.md)) - Workflow Box ([K181572](/device/K181572.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. MIM Software, Inc. % Ms. Lynn Hanigan Quality Assurance Director 25800 Science Park Drive, Suite 180 CLEVELAND OH 44122 Re: K193252 Trade/Device Name: Contour ProtégéAI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB Dated: June 1, 2020 Received: June 3, 2020 Dear Ms. Hanigan: 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ 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 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, 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) K193252 Device Name Contour ProtégéAI #### Indications for Use (Describe) Contour ProtégéAI is used by trained medical professionals as a tool to aid in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. Contour ProtégéAl assists in the following indications: The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. Segmenting normal structures across a variety of CT anatomical locations. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Contour ProtégéAI must be used in conjunction with MIM software to review and, if necessary, edit contours that were automatically generated by Contour ProtégéAI. | 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim SOFTWARE" in black. The word "mim" is in a larger font than the word "SOFTWARE". 510(k) Summary of Safety and Effectiveness (The following information is in conformance with 21 CFR 807.92) # K193252 #### Submitter: MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 | Phone: | 216-455-0600 | |------------------------|--------------| | Fax: | 216-455-0601 | | Contact Person: | Lynn Hanigan | | Date Summary Prepared: | 06/23/2020 | #### Device Name Trade Name: Contour ProtégéAl Common Name: Medical Imaging Software Requlation Number / Product Code: 21 CFR 892.2050 Product Code QKB Classification Name: System, Imaging Processing, Radiological #### Predicate Devices | K190379 | MIM on Linux | MIM Software Inc. | |---------|--------------|---------------------| | K181572 | Workflow Box | Mirada Medical Ltd. | #### Intended Use Contour ProtégéAl is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically. Contour ProtégéAl must be used in conjunction with MIM software to review and, if necessary, edit results automatically generated by Contour ProtégéAl. Contour ProtégéAl is not intended to detect or contour lesions automatically. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. ### Indications for Use Contour ProtégéAl is used by trained medical professionals as a tool to aid in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. Contour ProtégéAl assists in the following indications: - . The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. - Segmenting normal structures across a variety of CT anatomical locations. . - . And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images. Contour ProtégéAl must be used in conjunction with MIM software to review and, if necessary, edit contours automatically generated by Contour ProtégéAl. #### Device Description Contour ProtégéAl is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer. # Substantial Equivalence | ITEM | MIM Software Inc.
Contour ProtégéAl
(K193252) | MIM Software Inc.
MIM on Linux
(K190379) | Mirada Medical Ltd.
Workflow Box
(K181572) | |--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clearance Date | TBD | 03-19-2019 | 07-10-2018 | | Intended Use | Contour ProtégéAl is an
accessory to MIM software
used for the contouring of
anatomical structures in
imaging data using machine-
learning-based algorithms
automatically. | MIM software is intended for
trained medical professionals
including, but not limited to,
radiologists, oncologists,
physicians, medical
technologists, dosimetrists and
physicists. | Workflow Box is a system
designed to allow users to route
DICOM-compliant data to and
from automated processing
components.
Workflow Box includes
processing components for
automatically contouring
imaging data using deformable | | ITEM | MIM Software Inc. | MIM Software Inc. | Mirada Medical Ltd. | | | Contour ProtégéAl | MIM on Linux | Workflow Box | | | (K193252) | (K190379) | (K181572) | | | Contour ProtégéAl must be
used in conjunction with MIM
software to review and, if
necessary, edit results
automatically generated by
Contour ProtégéAl.
Contour ProtégéAl is not
intended to detect or contour
lesions automatically. | MIM is a medical image and
information management
system that is intended to
receive, transmit, store,
retrieve, display, print and
process digital medical images,
as well as create, display and
print reports from those images.
The medical modalities of these
medical imaging systems
include, but are not limited to,
CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0.
MIM provides the user with the
means to display, register and
fuse medical images from
multiple modalities.
Additionally, it evaluates
cardiac left ventricular function
and perfusion, including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction.
The Region of Interest (ROI)
feature reduces the time
necessary for the user to define
objects in medical image
volumes by providing an initial
definition of object contours.
The objects include, but are not
limited to, tumors and normal
tissues.
MIM provides tools to quickly
create, transform, and modify
contours for applications
including, but not limited to,
quantitative analysis, aiding
adaptive therapy, transferring
contours to radiation therapy
treatment planning systems
and archiving contours for | image registration and machine
learning based algorithms.
Workflow Box must be used in
conjunction with appropriate
software to review and edit
results generated automatically
by Workflow Box components,
for example image visualization
software must be used to
facilitate the review and edit of
contours generated by
Workflow Box component
applications.
Workflow Box is not intended to
automatically detect lesions. | | ITEM | MIM Software Inc.
Contour ProtégéAl
(K193252) | MIM Software Inc.
MIM on Linux
(K190379) | Mirada Medical Ltd.
Workflow Box
(K181572) | | | | patient follow-up and
management.
MIM aids in the assessment of
PET/SPECT brain scans. It
provides automated
quantitative and statistical
analysis by automatically
registering PET/SPECT brain
scans to a standard template
and comparing intensity values
to a reference database or to
other PET/SPECT scans on a
voxel by voxel basis, within
stereotactic surface projections
or standardized regions of
interest.
MIM allows the dose
distribution of an implant to be
individually shaped for each
patient and is a general-
purpose brachytherapy
planning system used for
prospective and confirmation
dose calculations for patients
undergoing a course of
brachytherapy using permanent
implants of various
radioisotopes (not including
radioactive microspheres).
MIM allows voxel-based dose
calculations for patients who
have been administered
radioisotopes or radioactive
microspheres. | | | Indications for Use | Contour ProtégéAl is used by
trained medical professionals
as a tool to aid in the automated
processing of digital medical
images of modalities CT and
MR, as supported by
ACR/NEMA DICOM 3.0. | MIM software is used by trained
medical professionals as a tool
to aid in evaluation and
information management of
digital medical images. The
medical image modalities
include, but are not limited to,
CT, MRI, CR, DX, MG, US, | Workflow Box is a software
system designed to allow users
to route DICOM-compliant data
to and from automated
processing components.
Supported modalities include
CT, MR, RTSTRUCT. | | ITEM | MIM Software Inc.
Contour ProtégéAl
(K193252) | MIM Software Inc.
MIM on Linux
(K190379) | Mirada Medical Ltd.
Workflow Box
(K181572) | | | Contour ProtégéAl assists in
the following indications:
The creation of
contours using
machine-learning
algorithms for
applications including,
but not limited to,
quantitative analysis,
aiding adaptive
therapy, transferring
contours to radiation
therapy treatment
planning systems, and
archiving contours for
patient follow-up and
management. Segmenting normal
structures across a
variety of CT
anatomical locations. And segmenting
normal structures of
the prostate, seminal
vesicles, and urethra
within T2-weighted MR
images. Contour ProtégéAl must be
used in conjunction with MIM
software to review and, if
necessary, edit contours that
were automatically generated
by Contour ProtégéAl. | SPECT, PET and XA as
supported by ACR/NEMA
DICOM 3.0. MIM assists in the
following indications:
Receive, transmit, store,
retrieve, display, print, and
process medical images
and DICOM objects. Create, display and print
reports from medical
images. Registration, fusion
display, and review of
medical images for
diagnosis, treatment
evaluation, and treatment
planning. Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic
volume, end-systolic
volume, and ejection
fraction. Localization and definition
of objects such as tumors
and normal tissues in
medical images. Creation, transformation,
and modification of
contours for applications
including, but not limited
to, quantitative analysis,
aiding adaptive therapy,
transferring contours to
radiation therapy
treatment planning
systems, and archiving
contours for patient follow-
up and management. Quantitative and statistical
analysis of PET/SPECT
brain scans by comparing
to other registered
PET/SPECT brain scans. | Workflow Box includes
processing components for
automatically contouring
imaging data using deformable
image registration to support
atlas-based contouring, re-
contouring of the same patient
and machine learning based
contouring.

Workflow Box is a data routing
and image processing tool
which automatically applies
contours to data which is sent
to one or more of the included
image processing workflows.
Contours generated by
Workflow Box may be used as
an input to clinical workflows
including, but not limited to,
radiation therapy treatment
planning.

Workflow Box must be used in
conjunction with appropriate
software to review and edit
results generated automatically
by Workflow Box components,
for example image visualization
software must be used to
facilitate the review and edit of
contours generated by
Workflow Box component
applications.

Workflow Box is intended to be
used by trained medical
professionals.

Workflow Box is not intended to
automatically detect lesions. | | ITEM | MIM Software Inc.
Contour ProtégéAl
(K193252) | MIM Software Inc.
MIM on Linux
(K190379) | Mirada Medical Ltd.
Workflow Box
(K181572) | | | | Planning and evaluation of permanent implant
brachytherapy procedures (not including radioactive
microspheres). Calculating absorbed radiation dose as a result
of administering a radionuclide. When using device clinically, the user should only use FDA
approved radiopharmaceuticals. If using with unapproved ones, this
device should only be used for research purposes.
Lossy compressed mammographic images and digitized film screen images
must not be reviewed for primary image interpretations. Images that are printed to film
must be printed using an FDA-approved printer for the diagnosis of digital
mammography images.
Mammographic images must be viewed on a display system that has been cleared by the
FDA for the diagnosis of digital mammography images. The software is not to be used for | | | Modalities | CT and MR | CT, MR, CR, DX, MG, US,
NM, PET, XA, and other
DICOM modalities | CT and MR | | ITEM | MIM Software Inc.
Contour ProtégéAl
(K193252) | MIM Software Inc.
MIM on Linux
(K190379) | Mirada Medical Ltd.
Workflow Box
(K181572) | | Atlas-based
Contour
Segmentation | No | Yes | Yes | | Automatically
Contour Imaging
Data Using
Machine-Learning | Yes | No | Yes | | Operating Platform | Server-based application
supporting
Linux-based OS | Microsoft® Windows,
Apple® OS,
Linux-based OS | Server based application
supporting
Microsoft Windows 10 (64-bit)
and
Microsoft Windows Server
2016 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color palette. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color palette. Contour ProtégéAl is substantially equivalent to a combination of the predicate devices MIM on Linux (K190379) and Mirada Workflow Box (K181572). # Testing and Performance Data The neural networks used in the Contour ProtégéAl device were trained on datasets from several large institutions. These datasets included CT images and MR images and their associated segmentations. For testing, 286 images were used to evaluate the neural network models that segmented CT images, while 72 images were used to evaluate for the MR segmentation network. In all cases, the test images were gathered from a different and disjoint set of institutions from the training data. Both Contour ProtégéAI and the MIM predicate device were used to automatically segmented the independent test sets to show substantial equivalence. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QKB/K193252](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QKB/K193252) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com