(61 days)
Not Found
No
The summary describes standard image processing and display functions, with no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as software for handling and displaying medical images for diagnostic interpretation, not for treatment or therapy.
Yes
The software is intended to support the diagnostic interpretation of Mammography studies by displaying medical images.
No
The device description explicitly states that its hardware components may include various hardware devices (digitizers, workstations, monitors, storage devices, etc.). While the software is a key part, the device is presented as a system that includes potential hardware components necessary for its intended use, particularly for mammography interpretation which requires specific FDA-cleared monitors.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is for "acceptance, transfer, display, storage and digital processing of medical images." It focuses on handling and manipulating images generated by medical imaging modalities (like X-ray, CT, MRI, etc.).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on bodily fluids or tissues.
The device is a medical image management and processing system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The PicomEnterprise software is intended for acceptance, transfer, display, storage and digital processing of medical images.
Its hardware components may include digitizers, workstations, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices and hardcopy devices.
The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
To support the diagnostic interpretation of Mammography studies, PicomEnterprise will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least five megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
The PicomEnterprise software is a multi-modality comprehensive two-, three- and four-dimensional image presentation software system intended for acceptance, transfer, display, storage and digital processing of medical images. The PicomEnterprise software combines reconstruction and display algorithms for medical image analysis in the familiar Microsoft Windows environment. PicomEnterprise offers full compliance with DICOM 3.0 standard that permit transfer of data from medical devices to storage server and then to other DICOM compliant devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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).
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K073169
pg. 1 of 2
Scimage
Sclmage, Inc. PicomEnterprise Software - 510(k) Premarket Notification
510(k) SUMMARY of Safety and Effectiveness
This following summary is provided as part of this Premarket Notification in compliance with and based on the format set forth in the Final Rule as published in the Federal Register, December 14, 1994. (See 21 CFR § 807.92)
(1) Submitters Name / Contact Information:
| Sclmage, Inc.
4916 El Camino Real
Suite 200
| Los Altos, California 94022 | JAN - 9 20+ |
|---|---|
| Contact Person: | Sai P. Raya, Founder & CEO |
| Tel.: (650) 694-4858 | |
| Fax: (650) 694-4861 | |
| E-mail: sai_raya@scimage.com | |
| Official Correspondent: | Regulatory Management Services |
| Gary J. Allsebrook - Consultant | |
| 16303 Panoramic Way | |
| San Leandro, CA 94578 | |
| Tel/Fax: (510) 276-2648 | |
| E-Mail: regman10@comcast.net | |
| Date prepared: | October 26, 2007 |
| (2) Name of device: |
| Trade Name: | PicomEnterprise |
|---|---|
| Common Name: | Medical image workstation system, PACS. |
| Classification Name: | §892.2050 Picture archiving and communications system |
(3) Identification of predicate device:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Scimage, Inc. | NetraTM Workstation and NetraMDTM Software | K960911 |
| Scimage, Inc. | NetraTM Workstation and NetraMDTM Software | K003484 |
| AMICAS | AMICAS Vision Series PACS 4.3 | K062477 |
(4) Description of the device:
The PicomEnterprise software is a multi-modality comprehensive two-, three- and four-dimensional image presentation software system intended for acceptance, transfer, display, storage and digital processing of medical images. The PicomEnterprise software combines reconstruction and display algorithms for medical image analysis in the familiar Microsoft Windows environment. PicomEnterprise offers full compliance with DICOM 3.0 standard that permit transfer of data from medical devices to storage server and then to other DICOM compliant devices.
1
K073169
pg. 2 of 2
Scimage
Sclmage, Inc. PicomEnterprise Software - 510(k) Premarket Notification
(5) A statement of the intended use of the device:
The PicomEnterprise software is intended for acceptance, transfer, display, storage and digital processing of medical images.
Its hardware components may include digitizers, workstations, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices and hardcopy devices.
The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
To support the diagnostic interpretation of Mammography studies, PicomEnterprise will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least five megapixel resolution and meets other technical specifications reviewed and accepted by FDA
(6) Predicate Device Comparison:
The PicomEnterprise software is substantially equivalent to similar features in the predicate devices and has the same intended uses and technological characteristics. The new features included in the modified software do not affect the safety or effectiveness of the device.
The modified device complies with the following voluntary standards as "Special Controls" to ensure safe and effective use:
- . ACR/NEMA Digital Imaging and Communications in Medicine (DICOM) standard
- Joint Photographic Experts Group (JPEG) standard .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines representing movement or connection.
JAN - 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scimage, Inc. % Mr. Gary J. Allsebrook Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116
Re: K073169
Trade/Device Name: PicomEnterprise Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 23, 2007 Received: November 9, 2007
Dear Mr. Allsebrook:
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, 1796, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ScImage Sclmage, Inc. PicomEnterprise - 510(k) Premarket Notification
2.0 FDA Indication for use form.
510(k) Number (if Known):
Device Name: PicomEnterprise
Indications For Use:
The PicomEnterprise software is intended for acceptance, transfer, display, storage and digital processing of medical images.
Its hardware components may include digitizers, workstations, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices and hardcopy devices.
The software components provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
To support the diagnostic interpretation of Mammography studies, PicomEnterprise will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least five megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Hormal M. Whan
Division of Reproductive, Abdomin Radiological Devices 510(k) Number
Section 1