FILMSAVER, NT VERSION 5.03

K021072 · American Medical Resources, Ltd. (Amr) · LLZ · Jun 6, 2002 · Radiology

Device Facts

• Record ID: K021072
• Device Name: FILMSAVER, NT VERSION 5.03
• Applicant: American Medical Resources, Ltd. (Amr)
• Product Code: LLZ · Radiology
• Decision Date: Jun 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

FilmSaver NT Version 5.03 is a software-based image processing tool designed to interface with standard radiology equipment (CT, MRI). It receives analog or digital radiological images, processes them using proprietary algorithms to reduce the area required for diagnostic display, and outputs the optimized images. By reducing the image area, the device decreases total film consumption. It is intended for use by radiology staff in clinical settings to improve workflow efficiency and reduce material costs associated with film printing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system; interfaces with industry-standard radiology equipment (CT, MRI); processes analog or digital radiological images; proprietary algorithm for image area reduction.

Indications for Use

Indicated for use in clinical radiology environments to reduce film consumption by optimizing diagnostic image area for CT and MRI modalities.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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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