(53 days)
The NDOHD system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.
The NDOнd High Definition Imaging System (NDOнD) previously acquired FDA clearance in 2013 as a Class II picture archiving and communication system that provides capabilities related to the acquisition, transfer, display, storage, and digital processing of images and videos (K131873). Altaravision replaced off the shelf hardware components due to the hardware becoming obsolete. Altaravision also updated the NDOHD software to enable use of the new hardware, improve the software user interface and conform to Apple's latest coding best practices.
The provided text is a 510(k) Summary for the Altaravision, Inc. NDŌHD High Definition Imaging System (NDOHD). This submission is for a modification to an already cleared device (K131873), primarily due to hardware obsolescence and software updates. It is a Picture Archiving Communications System (PACS) device.
Key takeaway: This is a 510(k) submission for an updated version of a previously cleared PACS device. The core of the submission is to demonstrate substantial equivalence to the predicate device, not to prove clinical efficacy through a new clinical trial against defined acceptance criteria for a novel AI algorithm.
Therefore, many of the typical questions regarding acceptance criteria for AI/ML devices and their associated studies (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not directly applicable or explicitly detailed in this type of submission, as the device is not an AI/ML diagnostic or assistive tool in the way that those questions imply. The testing described is primarily for software verification, system validation, and electrical safety, ensuring the new hardware and software function as intended and are as safe and effective as the predicate device.
However, I will extract relevant information where possible and explicitly state when a requested piece of information is not present or applicable.
Acceptance Criteria and Study to Prove Device Meets Criteria
Given that this is a 510(k) for an updated PACS system, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to the predicate device (NDŌHD High Definition Imaging System, K131873) in terms of intended use, indications for use, technological characteristics, and safety and effectiveness. The "study" is the collection of verification and validation testing performed.
1. Table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission for a PACS device update, the "acceptance criteria" are not presented as numerical performance targets (e.g., sensitivity, specificity) for a diagnostic task. Instead, they are implied through direct comparison to the predicate device across various characteristics and verification/validation testing. The performance is essentially reported as "equivalent" or "identical" to the predicate, with differences not affecting intended use, safety, or effectiveness.
| Acceptance Criterion (Implied by Substantial Equivalence Claim) | Reported Device Performance (Comparison to Predicate K131873) |
|---|---|
| Intended Use | Identical |
| Indications for Use | Identical |
| Target Population | Identical |
| Computer Hardware | Equivalent (MacBook Pro 13-inch and 15-inch vs. 15-inch; differences in specific models due to obsolescence, but functionally equivalent) |
| Display | Equivalent (Built-in computer display – 13-inch and 15-inch vs. 15-inch) |
| Storage Medium | Equivalent (Non-removable Solid State Drive (SSD) vs. Non-removable hard drive) |
| Operating System | Equivalent (macOS 10.14+ vs. macOS 10.8+; difference in version does not affect intended use or safety/effectiveness) |
| Camera Coupler | Identical (C-Mount) |
| Camera-Computer Cable | Different (USB-3.0 USB C to USB Micro-B vs. Firewire; difference does not affect intended use or safety/effectiveness) |
| Video Output Format | Different (.mp4 H.264 Video vs. .mov H.264 Video; difference does not affect intended use or safety/effectiveness) |
| Still Image Output Format | Identical (.tiff Image) |
| Camera Sensor Type | Different (CMOS vs. CCD Progressive; difference does not affect intended use or safety/effectiveness) |
| Camera Frame Rate | Different (203 fps vs. 31 fps; difference does not affect intended use or safety/effectiveness - note: higher frame rate is generally considered an improvement for video capture in this context, but framed as not impacting safety/effectiveness rather than a performance target met) |
| Pixel Size | Equivalent (4.8 μm x 4.8 μm vs. 4.65 μm x 4.65 μm) |
| Camera Bit Depth | Equivalent (10 bits vs. 8-14 bits) |
| Camera Resolution (H x V) | Different (1280 px x 1024 px vs. 1032 px x 776 px; difference does not affect intended use or safety/effectiveness - note: higher resolution is generally an improvement, but framed as not impacting safety/effectiveness) |
| Power Consumption | Equivalent (3 W (Typical) vs. < 4 W) |
| Lossy Image Compression | Identical (Yes, H.264 compression) |
| Power Source | Identical (Computer built-in battery operated) |
| Software Functionality | Equivalent (Controls recording, playback, storage, retrieval, live view of video, audio, images; updated UI, conform to Apple coding best practices) |
| Programming Language | Different (Swift vs. Objective C; difference does not affect intended use or safety/effectiveness) |
| Safety and Effectiveness | Demonstrated through software verification, system validation, and electrical safety testing according to FDA Guidance and Industry Standards (listed in Section 7). |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: This information is not provided in the summary. For a PACS system, validation testing would involve testing functionalities (acquisition, storage, display, retrieval, etc.) with various typical image/video files, but specific "test set" sizes for clinical evaluation (like for an algorithm) are not explicitly mentioned.
- Data Provenance: Not applicable in the context of this submission, as it's not evaluating clinical data for diagnoses made by the system. The system handles endoscopic and fluoroscopic procedure videos and images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is a PACS system for managing images, not an AI diagnostic tool requiring expert-established ground truth for performance evaluation of a clinical task.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable for the reasons stated above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not performed. This device is a PACS system, not an AI assistant intended to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A "standalone" performance evaluation in the context of a diagnostic algorithm is not applicable. The device's performance relates to its ability to acquire, store, display, and retrieve images/videos correctly and safely, which was evaluated through verification and validation (V&V) testing, not through standalone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" in the diagnostic sense (e.g., pathology for cancer detection) is not applicable to this PACS system. The V&V testing would establish that functionalities (e.g., image integrity, compression, display fidelity, storage/retrieval accuracy) meet their specifications, rather than clinical ground truth.
8. The sample size for the training set:
- This device is not an AI/ML algorithm that is "trained" on a dataset in the typical sense. Therefore, a "training set" sample size is not applicable. The software was updated and developed following coding best practices, and subjected to verification and validation.
9. How the ground truth for the training set was established:
- As the device is not an AI/ML algorithm with a "training set," this question is not applicable.
{0}------------------------------------------------
510(k) Summary
Altaravision, Inc. K190420
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | Altaravision, Inc.130 Salem Town CourtApex, NC 27502Phone: 919-342-5778 |
|---|---|
| Primary Contact: | Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979 |
| Company Contact: | Stuart BradleyChief Executive Officer |
| Date Prepared: | April 12, 2019 |
Device Name and Classification
| Trade Name: | NDŌHD High Definition Imaging System (NDŌHD) |
|---|---|
| Common Name: | Picture Archiving Communications System (PACS) |
| Classification: | Class II |
| Regulation Number: | 892.2050- Picture Archiving and Communications System (PACS) |
| Classification Panel: | Radiology |
| Product Code: | LLZ |
Predicate Device:
| Primary Predicate | |
|---|---|
| Trade Name | NDŌHD High Definition Imaging System (NDŌHD) |
| Common Name | Picture Archiving Communications System (PACS) |
| 510(k) Submitter / Holder | Altaravision, Inc. |
| 510(k) Number | K131873 |
| Regulation Number | 892.2050- Picture Archiving and Communications System (PACS) |
| Classification Panel | Radiology |
| Product Code | LLZ |
{1}------------------------------------------------
Device Description and Intended Use
The NDOнd High Definition Imaging System (NDOнD) previously acquired FDA clearance in 2013 as a Class II picture archiving and communication system that provides capabilities related to the acquisition, transfer, display, storage, and digital processing of images and videos (K131873). The NDOнD High Definition Imaging System (NDOHD) previously acquired FDA clearance in 2013 as a Class II picture archiving and communication system (K131873). Altaravision replaced off the shelf hardware components due to the hardware becoming obsolete. Altaravision also updated the NDOHD software to enable use of the new hardware, improve the software user interface and conform to Apple's latest coding best practices.
The NDŌнь system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures.
Indications for Use
The NDŌнь system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.
Risk Analysis Method
Risk Management activities were completed following ISO 14971:2007 and ISO 14971:2012 and Altaravision's current Risk Management Procedure, SOP 1070, in order to assess the impact of the modification on the device and its components. A Risk Management Plan was created to identify the risk management team, the risk acceptability criteria, and the plan for completion of a risk assessment and risk management report. Hazards for the new system were identified systematically using the device safety characteristics, and reviewing known hazards and hazard categories. Hazards related to the use of off the shelf software were also incorporated in the Risk Assessment. Risk was then evaluated using the established risk acceptability criteria and taking into account current controls of the system. Risks were then further evaluated after additional controls were taken into account. From here, residual risk was evaluated, and it was determined if a risk benefit analysis was necessary. All risks were found to be acceptable, and no risk benefit analysis was necessary. After the completion of the Risk Assessment, the overall risk and residual risk of the NDOнь 2.1 system has been found to be acceptable by executive management.
Substantial Equivalence
The table below provides a detailed comparison of the NDŌнɒ High Definition Imaging System to the predicate device.
{2}------------------------------------------------
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| NDŌHD High DefinitionImaging System, version 2.1 | NDŌHD High Definition ImagingSystem (K131873) | ||
| Intended Use | The NDŌHD system is intendedfor viewing, acquiring, recording,archiving and retrieving videoand still images of endoscopicand fluoroscopic procedures. | The NDŌHD system is intendedfor viewing, acquiring, recording,archiving and retrieving video andstill images of endoscopic andfluoroscopic procedures. | NDŌHD High Definition ImagingSystem Version 2.1 is identical toNDŌHD High Definition ImagingSystem (NDŌHD ). |
| Indications forUse | The NDŌHD system is intendedfor viewing, acquiring, recording,archiving and retrieving videoand still images of endoscopicand fluoroscopic procedures.The professionals orpractitioners using this systemwould be medical doctors orclinicians such as speechpathologists. The device is aprescription device. The NDŌHDsystem is not intended to beused in an environment thatrequires sterilization. | The NDŌHD system is intendedfor viewing, acquiring, recording,archiving and retrieving video andstill images of endoscopic andfluoroscopic procedures. Theprofessionals or practitionersusing this system would bemedical doctors or clinicians suchas speech pathologists. Thedevice is a prescription device.The NDŌHD system is notintended to be used in anenvironment that requiressterilization. | NDŌHD High Definition ImagingSystem Version 2.1 is identical toNDŌHD High Definition ImagingSystem (NDŌHD ). |
| Target Population | Medical doctors or clinicianssuch as speech pathologists | Medical doctors or clinicians suchas speech pathologists | NDŌHD High Definition ImagingSystem Version 2.1 is identical toNDŌHD High Definition ImagingSystem (NDŌHD ). |
| Computer | MacBook Pro 13-inch and 15-inch | MacBook Pro 15-inch | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem (NDŌHD ). |
| Item | Subject Device | Predicate Device | Comparison |
| NDŌHD High DefinitionImaging System, version 2.1 | NDŌHD High Definition ImagingSystem (K131873) | ||
| Display | Built-in computer display – 13-inch and 15-inch | Built-in computer display – 15-inch | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem (NDŌHD ). |
| Storage Medium | Non removable solid state drive(SSD) | Non removable hard drive | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem (NDŌHD ). |
| Operating System | macOS 10.14 + | macOS 10.8 + | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem (NDŌHD ), with the onlydifference being the version of theoperating system. This differencedoes not affect the intended use orsafety and effectiveness of thedevice. |
| Camera Coupler | C-Mount | C-Mount | NDŌHD High Definition ImagingSystem Version 2.1 is identical toNDŌHD High Definition ImagingSystem (NDŌHD ). |
| Camera –Computer Cable | USB-3.0 USB C to USB Micro-B | Firewire | NDŌHD High Definition ImagingSystem Version 2.1 uses a differentcable than the NDŌHD HighDefinition Imaging System. This |
| Item | Subject Device | Predicate Device | Comparison |
| NDŌHD High DefinitionImaging System, version 2.1 | NDŌHD High Definition ImagingSystem (K131873) | ||
| difference does not affect theintended use or safety andeffectiveness of the device. | |||
| Video OutputFormat | .mp4 H.264 Video | .mov H.264 Video | The video output format of theNDŌHD High Definition ImagingSystem Version 2.1 is different fromthe video output format used with theNDŌHD High Definition ImagingSystem. The difference in videoformat does not affect the intendeduse or safety and effectiveness of thedevice. |
| Still Image OutputFormat | .tiff Image | .tiff Image | NDŌHD High Definition ImagingSystem Version 2.1 is identical toNDŌHD High Definition ImagingSystem. |
| Camera SensorType | CMOS | CCD Progressive | The camera sensor type of theNDŌHD High Definition ImagingSystem Version 2.1 is different fromthe one used with the NDŌHD HighDefinition Imaging System. Thisdifference does not affect theintended use or safety andeffectiveness of the device. |
| Camera FrameRate | 203 fps (frames per second) | 31 fps (frames per second) | The camera frame rate of the NDŌHDHigh Definition Imaging System |
| Item | Subject Device | Predicate Device | Comparison |
| NDŌHD High DefinitionImaging System, version 2.1 | NDŌHD High Definition ImagingSystem (K131873) | ||
| Version 2.1 is different from the oneused with the NDŌHD High DefinitionImaging System. This differencedoes not affect the intended use orsafety and effectiveness of thedevice. | |||
| Pixel Size | 4.8 μm x 4.8 µm | 4.65 μm x 4.65 μm | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem. |
| Camera Bit Depth | 10 bits | 8 - 14 bits | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem. |
| CameraResolution (H x V) | 1280 px x 1024 px | 1032 px x 776 px | The camera resolution used in theNDŌHD High Definition ImagingSystem Version 2.1 is different fromthe one used with the NDŌHD HighDefinition Imaging System. Thisdifference does not affect theintended use or safety andeffectiveness of the device. |
| PowerConsumption | 3 W (Typical) | < 4 W | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem. |
| Item | Subject Device | Predicate Device | Comparison |
| NDŌHD High DefinitionImaging System, version 2.1 | NDŌHD High Definition ImagingSystem (K131873) | ||
| Lossy ImageCompression | Yes, H.264 compression | Yes, H.264 compression | NDŌHD High Definition ImagingSystem Version 2.1 is identical toHigh Definition Imaging System. |
| Power Source | Computer built in batteryoperated | Computer built in batteryoperated | NDŌHD High Definition ImagingSystem Version 2.1 is identical topower source of the NDŌHD HighDefinition Imaging System. |
| Software | NDŌHD Software is used tocontrol the recording, playback,storage, retrieval, and live viewof high definition video (.mp4),audio and images (.tiff) data. | NDŌHD Software is used tocontrol the recording, playback,storage, retrieval, and live view ofhigh definition video (.mov), audioand images (.tiff) data. | NDŌHD High Definition ImagingSystem Version 2.1 is equivalent toNDŌHD High Definition ImagingSystem. |
| ProgrammingLanguage | Swift | Objective C | The programming language of theNDŌHD High Definition ImagingSystem Version 2.1 is different fromthe programming language of theNDŌHD High Definition ImagingSystem. This difference does notaffect the intended use or safety andeffectiveness of the device. |
{3}------------------------------------------------
{4}------------------------------------------------
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
Testing
Software verification, system validation, and electrical safety testing have been completed according to FDA Guidance and Industry Standards as follows:
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
- . Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000
- . Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices. September 9, 1999
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012. Medical . Electrical Equipment Part 1: General Requirements for Safety
- . CAN/CSA C22.2 No. 60601-1:14
- IEC 60601-2-18:2009. Medical electrical equipment Part 2-18: Particular requirements ● for the basic safety and essential performance of endoscopic equipment
- . IEC 60601-1-2:2014 4th Edition, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- . IEC 62304: 2006, Medical device software - Software life cycle processes
Substantial Equivalence Conclusions
In conclusion, the intended use for NDOHD High Definition Imaging System, version 2.1 is the same as that of the NDOHD High Definition Imaging System (K131873). The technological characteristics demonstrate that the NDOHD High Definition Imaging System, version 2.1 is equivalent to the NDÕнɒ High Definition Imaging System, and the testing shows that the NDOഫ High Definition Imaging System, version 2.1 is substantially equivalent to the NDO็นo High Definition Imaging System (K131873) and assures that the NDOнD High Definition Imaging System, version 2.1 is as safe and effective as the NDOHD High Definition Imaging System (K131873).
Conclusion
The 510(k) Pre-market Notification for the NDOnD High Definition Imaging System contains adequate information and data to determine that the Altaravision, Inc. NDÔнь High Definition Imaging System is as safe and effective as the legally marketed predicate device(s).
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, reflecting the organization's role in regulating food and drugs.
Altaravision Inc. % Ms. Rita King CEO MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville, North Carolina 27560
April 15, 2019
Re: K190420
Trade/Device Name: NDOHD High Definition Imaging System (NDOHD) Regulation Number: 21 CFR 892.20507 Regulation Name: Picture Archiving and Communications System. Regulatory Class: Class II Product Code: LLZ Dated: March 15, 2019 Received: March 19, 2019
Dear Rita King:
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
{9}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications for Use
510(k) Number (if known) K190420
Device Name NDOHD High Definition Imaging System (NDOHD)
Indications for Use (Describe)
The NDOHD system is intended for viewing, acquiring, archiving and retrieving video and still images of endoscopic and fluoroscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.
Type of Use (Select one or both, as applicable)
| [X] Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| [] Over-The-Counter Use (21 CFR 801 Subpart C) |
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."
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).