COBRASCAN CR-1 FILMLESS

K022810 · Radiographic Digital Imaging, Inc. · LMA · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K022810
• Device Name: COBRASCAN CR-1 FILMLESS
• Applicant: Radiographic Digital Imaging, Inc.
• Product Code: LMA · Radiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.

Device Story

Cobrascan CR-1 Filmless is a computed radiography dual technology scanner; functions as an enhanced modification of the Cobrascan CX-312T. Device accepts x-ray film and phosphor imaging plates as input; performs digitization and processing of diagnostic images. Used in clinical environments by healthcare professionals to convert analog x-ray data into digital format. Output allows clinicians to view, store, and analyze diagnostic images, facilitating clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computed radiography dual technology scanner; utilizes CCD (charge-coupled device) technology for x-ray film digitization and phosphor imaging plate scanning. Standalone device for image processing.

Indications for Use

Indicated for the identification, capture, digitization, and processing of diagnostic x-ray images from x-ray film and phosphor imaging plates in a clinical setting.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*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.

Predicate Devices

• Cobrascan CX-312T (K953942)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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### 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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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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# 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