(28 days)
Not Found
Not Found
No
The summary describes a basic image scanner that digitizes X-ray film. There is no mention of any analytical or interpretive functions, nor any terms related to AI or ML.
No
The device is an image scanner that reads images from X-ray film and transfers them as digital data to a computer; it does not perform any therapeutic function.
No
The device is described as an image scanner that digitizes X-ray film, transferring images to a computer. It does not perform interpretation or analysis of these images for diagnostic purposes.
No
The device is described as an "image scanner" which reads images from X-ray film using transmitted light. This description clearly indicates a physical hardware component (the scanner itself) is involved in the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description states the device reads images from "X-ray film and the like," which are not specimens derived from the human body.
- IVDs are used to provide information for the diagnosis, monitoring, or treatment of a disease or condition. While the output of this device (digital X-ray images) can be used in a diagnostic process, the device itself is simply a scanner that digitizes existing images. It does not perform any analysis or provide diagnostic information directly from a biological sample.
- The intended use describes the device as an "image scanner" that reads and transfers images. This aligns with the function of a general-purpose image digitizer, not an IVD.
The description clearly indicates the device's function is to digitize existing images (like X-ray films) for transfer to a computer. This is a step in a potential diagnostic workflow, but the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.
Product codes
90 LMA
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray film
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel
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): 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.
Not Found
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).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2003
Mr. Takashi Inami Manager Research & Development Dept. Array Corporation 3-42-10 Yoyogi, Shibuya-ku Tokyo, 151-0053 JAPAN
Re: K033637
Trade/Device Name: Film Digitizer, Model 2908 Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: November 5, 2003 Received: November 19, 2003
Dear Mr. Inami:
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 such 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. brigdon
Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
2
KO33637 510(k) Number (If known): Not known
Device Name: Film Digitizer, Model 2908
Indications for Use:
Model 2908 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images, as the digital data, to a computer.
This device has no patient contacting materials and is intended to be used by trained personnel only.
The output of the device is to be evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention In case of malfunction.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use √
OR Over The Counter Use
(Optional Format 1-2-96)
Hancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033637