(94 days)
Not Found
Not Found
No
The provided 510(k) summary focuses on image storage and retrieval and does not mention AI, ML, or any related technologies or performance metrics typically associated with AI/ML-powered devices.
No
This device is described as storing and retrieving images and patient information from various radiological modalities. Its intended use does not involve treating or diagnosing a disease, which are criteria for a therapeutic device. It is an image management system.
No
The intended use describes the device as storing and retrieving images and patient information, which is a function of an image management system (like PACS), not a diagnostic device that analyzes images to aid in diagnosis.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. While it describes the intended use with various imaging modalities, it doesn't explicitly state whether the device is purely software or includes hardware components for image storage and retrieval.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "store and retrieve images and patient information" from various radiological modalities. This describes a system for managing medical images, not a test performed on biological samples to diagnose a condition.
- Device Description: While "Not Found" is listed, the intended use clearly points away from IVD activities.
- No mention of biological samples: IVDs are designed to analyze biological samples (blood, urine, tissue, etc.). There is no mention of any such analysis in the provided text.
- Focus on image management: The core function described is the handling and storage of medical images.
Therefore, this device falls under the category of a medical image management system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI, ultrasound, nuclear medicine, CR, DR, etc.
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)
Not Found
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).
0
Public Health Service
FEB 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Visus Technology Transfer GmbH % Mr. Stephen Neushul President iCRco, Inc. 20406 Earl Street TORRENCE CA 90503
Re: K053183 Trade/Device Name: JiveX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 13, 2006 Received: January 17, 2006
Dear Mr. Neushul:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becaller 5 re(ts) prohestantially equivalent (for the indications for use stated in above and nave dolorinined the at reedicate devices marketed in interstate commerce prior to the cherosure to regary manteled probectical Device Amendments, or to devices that have been May 20, 1770, the onaominent and of the Federal Food, Drug, and Cosmetic Act (Act) that recials in accordation in accordation (PMA). You may, therefore, market the do not require approval of a premience approvisions of the Act. The general controls provisions of the Act device, subject to the general comeon prove, isting 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 (Premarket If your device is classined (500 acch additional controls. Existing major regulations affecting your Approval), it they be subject to additions, 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 I lease be advised that very in 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 r carrar statues and regulating, 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) (21 CFR Part 80 FR 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) This letter will anow you to begin mankemig your and equivalence of your device to a legally premarket notification. The PDA miding of subscantul vice 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 If you desire specific advice for your device on our labeling organisms, 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 Also, please note the regulation chilities, "Thisotanana on your responsibilities under the Act from the 180 807.97). You may obtain other general information your copyright 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.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
2
Indications for Use
510(k) Number (if known): K053183
Device Name: JiveX
Indications For Use:
To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
David A. Seppon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number .
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)