(59 days)
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Not Found
No
The summary describes standard medical image processing and management functionalities (DICOM, storage, display, digitization) without mentioning AI, ML, or related concepts like algorithms for image analysis or interpretation beyond basic processing.
No.
Explanation: The device is intended for image management (acceptance, transfer, display, storage, digitization, and digital processing of medical images), not for directly treating or diagnosing patients.
No
The intended use states the device is for the acceptance, transfer, display, storage, digitization, and digital processing of medical images. It does not state that the device is used to diagnose diseases or conditions.
No
The device description explicitly mentions "digitization of film images," which implies the use of hardware (a digitizer) to convert physical film into digital images. This component is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Filmless Clinic's Intended Use: The intended use of Filmless Clinic is focused on the management and processing of medical images (like X-rays, CT scans, etc.). It deals with the acceptance, transfer, display, storage, digitization, and digital processing of these images.
- Lack of Specimen Handling: There is no mention of the device interacting with or analyzing biological specimens from the human body.
Therefore, Filmless Clinic falls under the category of medical imaging devices or picture archiving and communication systems (PACS), not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images.
Filmless Clinic is intended for use by qualified physicians and radiologists and other personnel.
Product codes
90 LLZ
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
No
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
qualified physicians and radiologists and other personnel.
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.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/1 description: The image is a black and white seal. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
JUL 3 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Philip J. Manly President Connect Imaging, Inc. 850 West Hind Drive, # 214 Honolulu, HI 96821
Re: K031704
Trade/Device Name: FilmLess Clinic Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: May 23, 2003 Received: June 6, 2003
Dear Mr. Manly:
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 vours.
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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Page 1 of 1
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K_03 1764
Device Name: FILMLESS CLINIC
Indications for Use:
Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images.
Filmless Clinic is intended for use by qualified physicians and radiologists and other personnel.
David A. Lyon
(Division Sign-Off Division of Reproductive Ahdominal and Radiological Dev 510(k) Number
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)