(49 days)
No
The summary describes a computed radiography scanner that digitizes x-ray images. It mentions "processing of diagnostic x-ray images" but does not include any terms related to AI, ML, deep learning, or neural networks, nor does it describe any AI/ML-specific performance metrics or training/test data.
No
The device is described as a scanner for processing diagnostic x-ray images, not for treating diseases or conditions.
No
This device digitizes and processes pre-existing diagnostic x-ray images; it does not independently diagnose conditions.
No
The device description explicitly states it is a "computed radiography dual technology scanner" and an "enhanced modification of the Cobrascan CX-312T (FDA #K953942) CCD x-ray film digitizer," indicating it is a hardware device with associated software for image processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "identification, capture, digitization and processing of diagnostic x-ray images." This describes a process of handling and converting existing diagnostic images, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is described as a "computed radiography dual technology scanner" and an "x-ray film digitizer." These are imaging devices, not devices used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information based on laboratory results
The device's function is to convert physical x-ray films and phosphor plates into digital images for viewing and processing. This is a crucial step in the diagnostic workflow, but the device itself is not performing the diagnostic test. The diagnosis is made by a healthcare professional interpreting the processed images.
N/A
Intended Use / Indications for Use
The Cobrascan CR-1 Filmless is a computed radiography dual technology scanner. It is an enhanced modification of the Cobrascan CX-312T (FDA #K953942) CCD x-ray film digitizer. The indications for use of the Cobrascan CR-1 Filmless is: the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.
Product codes
90 LMA
Device Description
The Cobrascan CR-1 Filmless is a computed radiography dual technology scanner. It is an enhanced modification of the Cobrascan CX-312T (FDA #K953942) CCD x-ray film digitizer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its head, representing the department's commitment to health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Ms. Analei Samaseia Director of Operations Radiographic Digital Imaging, Inc. 20406 Earl Street TORRANCE CA 90503
Re: K022810 Trade/Device Name: Cobrascan CR-1 Filmless
Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: August 19, 2002 Received: August 23, 2002
Dear Ms. Samaseia:
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 (sec 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 lisung. (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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Page 2
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
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KC22810
STATEMENT OF INDICATIONS FOR USE
The Cobrascan CR-1 Filmless is a computed radiography dual technology scanner. It is an enhanced modification of the Cobrascan CX-312T (FDA #K953942) CCD x-ray film digitizer.
The indications for use of the Cobrascan CR-1 Filmless is: the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.
Radiographic Digital Imaging, Inc. 510 (k) Premarket Notification
Statement of Indication of Use
APPENDIX D
Prescription Use
(Per 21 CFR 801.109)
David A. Heyman
(Division Sign-Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number
510(k) Premarket Notification Radiographic Digital Imaging, Inc. CR-1 Filmless Statement of Indications for Use August 19,2002