(65 days)
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Not Found
No
The summary mentions "propriety software algorithms" for image processing but does not explicitly mention AI, ML, deep learning, or any related concepts. There is also no information about training or test sets, which are typically associated with ML/AI development.
No.
The device's intended use is to reduce film consumption by reducing the area needed for diagnostic images, which is an administrative or image management function, not a therapeutic one.
No
The device is described as software that reduces film consumption by reducing the area needed for diagnostic images, and it processes and sends radiological images. Its intended use is focused on optimizing film usage, not on interpreting or analyzing images to provide a diagnosis or aid in diagnostic decisions.
Yes
The device description explicitly states "FilmSaver NT Version 5.03 software" and the intended use describes software algorithms for processing images, with no mention of accompanying hardware components being 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 of FilmSaver NT is to process and reduce the area of radiological images (CT, MRI, etc.). These are images of the body, not specimens taken from the body (like blood, urine, tissue samples, etc.).
- The description focuses on image processing for film reduction. The primary function described is reducing the film area needed for diagnostic images, which is a technical process related to image display and storage, not a diagnostic test performed on a biological sample.
Therefore, FilmSaver NT Version 5.03 software, as described, falls outside the scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
FilmSaver NT Version 5.03 software is intended to reduce the total film consumption of a CT scanner, MRI, etc. by reducing the area needed for the diagnostic image. The device uses propriety software algorithms to receive, process, and send analog or digital radiological images. The FilmSaver product is designed to interface with industry standard radiology equipment.
Product codes
90 LLZ
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
CT scanner, MRI, etc.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
Not Found
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.
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).
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§ 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
Image /page/0/Picture/13 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with three human profiles within the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ועות 6 2002
American Medical Resources, Ltd. % Ms. Elizabeth N. Faulstich Ouality Assurance Manager Equipment Engineering Services, P.A. 3501 Silverside Road. Suite 205 WILMINGTON DE 19810
Re: K021072
Trade/Device Name: FilmSaver NT.Version 5.03 FilmSaver Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: March 31, 2002 Received: April 2, 2002
Dear Ms. Faulstich:
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 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 this 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" (21 CFR Part 807.97). 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
2
KO2101Z
Appendix Indications for Use Statement
510(k) Number: (if known) K021072
Applicant: Chris Kulp of American Medical Resources, Ltd.
Device Name: FilmSaver NT Version 5.03
Indications for Use:
、・ .
FilmSaver NT Version 5.03 software is intended to reduce the total film consumption of a CT scanner, MRI, etc. by reducing the area needed for the diagnostic image. The device uses propriety software algorithms to receive, process, and send analog or digital radiological images. The FilmSaver product is designed to interface with industry standard radiology equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR Section §801.109)
David h. Llymm
(Division Sign-Off Division of Reproductiv and Radiological Devi 510(k) Number
Prescription Use