(64 days)
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Not Found
No
The summary describes basic image acquisition, storage, and transmission software without mentioning any analytical or processing capabilities that would typically involve AI/ML.
No.
The intended use and device description state that the software is used to acquire, store, transmit, and view image or patient data, which are functions related to data management and visualization, not directly for treating or alleviating a medical condition.
No
The device is described as software used to acquire, store, transmit, and view image or patient data, which are functions related to data management and communication, not for diagnosing conditions.
Yes
The device description explicitly states "Digital Imager software" and describes its functions as acquiring, storing, transmitting, and viewing data, all of which are software-based operations. There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description state that the software is used to acquire and store image or patient data. While this data might be related to a patient, there is no mention of analyzing biological specimens (like blood, urine, tissue, etc.) in vitro (outside the body).
- The function is data management and viewing. The primary functions described are acquiring, storing, transmitting, and viewing image and patient data. This is a data management and visualization tool, not a diagnostic test performed on a specimen.
The software appears to be a system for handling medical images and associated patient information, which is common in various medical imaging modalities (like X-ray, CT, MRI, etc.). However, the software itself is not performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection. Typical users of this system are trained professionals, including but not limited to physicians, technicians and nurses.
Product codes
90 LMA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained professionals, including but not limited to physicians, technicians and nurses.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three wavy lines emanating from its body, symbolizing health and well-being. The agency's name is written around the circular border of the logo.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
SEP - 2 2003
Mr. Claude Burnett President Pyramid Medical, Inc. 10940 Portal Dr. LOS ALAMITOS CA 90720 Re: K032022
Trade/Device Name: Digital Imager Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: June 20, 2003 Received: June 30, 2003 .
Dear Mr. Burnett:
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.
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); 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.
1
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Digital Imager
Indications For Use:
The Digital Imager software is used to acquire and store image or patient data. This data can then be transmitted, stored and viewed over a computer network or off-site using an internet connection. Typical users of this system are trained professionals, including but not limited to physicians, technicians and nurses.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devic 510(k) Number
Prescription Use