(56 days)
No
The summary describes basic image processing, display, annotation, and measurement functionalities, with no mention of AI, ML, deep learning, or any related concepts.
No
The device is described as software that processes and presents medical images for display, and it specifically states it "must not be used for primary image diagnosis in mammography." Its function is for image visualization and enhancement, not for treating or diagnosing medical conditions itself.
No
The CO pilot software primarily processes and presents medical images, and explicitly states it "must not be used for primary image diagnosis in mammography." While it allows for annotations and measurements, its core function is image display and manipulation, not drawing diagnostic conclusions.
No
The device is described as "software" but is explicitly intended for installation on a specific, pre-existing hardware system (REGIUS Unitea, K071436). While the software performs image processing and display functions, its operation is dependent on and integrated with this hardware platform, making it a component of a larger system rather than a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The CO pilot software is described as facilitating the processing and presentation of medical images from various imaging modalities (X-ray, CT, MRI, Ultrasound, Nuclear Medicine). It also provides tools for annotation and measurement on these images.
- Lack of Specimen Analysis: There is no mention of the CO pilot software analyzing any biological specimens. Its function is solely related to the manipulation and display of medical images acquired through non-invasive imaging techniques.
Therefore, the CO pilot software falls under the category of medical image processing and display software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea / 510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.
Product codes
90LLZ
Device Description
The "CO Pilot Software" is intended for installation on REGIUS Unitea (510(K) number: K071436), and provides unit for creating display-use annotation such as line, curve, and character information, unit for measuring the distance between 2 points and angle formed between 3 points and Transfer GUI data to the GUI control module to REGIUS Unitea System Control Program
Mentions image processing
The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
510(k) Summary
as required by 807.92
1. Company Identification
Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Establishment Registration Number: 3004485675
2. Submitter's Name and Address
Shigeyuki Kojima Manager Requlations and Standards Section, Quality Assurance Center No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Telephone: 81-42-589-8429 Fax: 81-42-589-8053
3. Date of Submission November 29, 2013
November 29, 2013
-
- Device Trade Name CO Pilot
5. Common Name
Picture Archiving Communications System
6. Classification, Product Code Class II , 90LLZ
7. Predicate Device
REGIUS Unitea, 510(k) number K071436 Acies, 510(k) number K101842 Opal-RAD TM, 510(k) number K063337
8. Device Description
The "CO Pilot Software" is intended for installation on REGIUS Unitea (510(K) number: K071436), and provides unit for creating display-use annotation such as line, curve, and character information, unit for measuring the distance between 2 points and angle formed between 3 points and Transfer GUI data to the GUI control module to REGIUS Unitea System Control Program
9. Indications for Use
The CO pilot is intended for installation on an off-the-shelf PC (console of REGIUS Unitea / 510(K) number: K071436) for meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and
JAN 3 1 2014
1
other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.
10. Substantial Equivalence to Predicate Device
The predicate devices of CO Pilot are Picture Archiving Communications System (K071436, K101842, and K063337).
A comparison of the Indications for Use. Configuration. Specifications, and Principal of Operation of this proposed device and the predicate devices are almost identical or within a scope of substantial equivalent, the materials, the electrical safety (JEC 60601-1) and the electromagnetic compatibility testing (IEC 60601-1-2) won't be issue for this proposed device.
In technological characteristics, Verification and Validation, Risk management based on ISO14971 had been completed without problem. Verification and Validation showed equivalent evaluation outcome with the predicate devices, which has supported a fact that no impacts in technological characteristics such as design, material chemical composition energy sauce and other factors of the proposed device were recognized
The all evaluation results can assure that there is no safety, effectiveness and performance issue or no differences were found in further than the predicate devices have which has been regally marketed the United States. Therefore, we confirmed that the function quality of proposed device has the substantial equivalency with orthopedic or chiropractic supporting functions quality that predicate devices have. .
11. Conclusion
Comprehensively, we conclude that the CO Pilot has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.
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Page 3—Mr. Munves
-------------REMOVE THIS PAGE WHEN PRINTING OR EMAILING TO SPONSOR---------510(k) Number: K133730 - Konica Minolta, Inc.
| Digital Signature Concurrence Table | |
|---|---|
| Reviewer Sign-Off | Yanna Kang |
| January 29, 2014 | |
| Branch Chief Sign-Off | Robert Ochs |
| January 29, 2014 | |
| Division Sign-Off | Sean M. Boyd -S |
| 2014.01.31 | |
| 15:34:53 -05'00' |
QC: FMEba:fme:1729/2014
Template Name: OIR Letter Generator v1.10 - Letter type: SE
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms, representing care and protection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60S Silver Spring, MD 20993-0002
January 31, 2014
Konica Minolta Inc. % Mr. Russell Munves STORCH, AMINI & MUNVES, P.C. 140 East 45th Street, 25th Floor Two Grand Central Tower NEW YORK NY 10017
Re: K133730
Trade/Device Name: Co Pilot/REGIUS Unitea Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 2, 2013 Received: December 6, 2013
Dear Mr. Munves:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Mr. Munves
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safets/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
ரொ
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known) : K133730
Device Name
CO Pilot
Indications for Use:
The CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea / 510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.
Prescription Use_ x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k)_K133730