MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001

K051494 · Cr Tech, Ltd. · MQB · Sep 21, 2005 · Radiology

Device Facts

• Record ID: K051494
• Device Name: MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
• Applicant: Cr Tech, Ltd.
• Product Code: MQB · Radiology
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CDCR5020s,UCCR7001 and TCCR7001 are intended to be used in radiological practices as laser digitizers for phosphor storage plate. The images are sent for processing to a PC. 1. Model CDCR 5020s This device is used on cassette based x-ray systems using the standard Buckey exist on every system. After exposing the cassette which includes the phosphor plate ,the plate is digitized and the digital image is transferred to the PC for processing 2. Models UCCR 7001 ,TCCR 7001 With these two devices the organ or object for x-ray exposure are positioned In the front of the device (near the phosphor plate which is positioned into the device) and after exposure the digitizing process is taking place,then the Digital image is transferred to the PC for processing. The only difference in the models are the way of use eather Vertical for Upright or horizontal under the Radiographic Table. ALL ABOVE MODELS ARE NOT TO BE USED FOR MAMMOGRAPHY

Device Story

Device functions as laser digitizer for phosphor storage plates; inputs include exposed phosphor plates from x-ray systems. CDCR 5020s utilizes standard Bucky cassette-based systems; UCCR 7001 and TCCR 7001 are cassetteless systems where object is positioned directly in front of device. Digitization process converts latent x-ray image on phosphor plate into digital signal; output transferred to PC for processing. Used in clinical radiological settings; operated by radiology staff. Provides digital images for diagnostic review; facilitates transition from analog to digital radiography workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laser-based phosphor storage plate digitizer. Models differ by orientation (vertical/upright vs. horizontal/table-based). Connectivity via PC interface for image processing. Software-based digitization of phosphor plate signals.

Indications for Use

Indicated for use in radiological practices as laser digitizers for phosphor storage plates in cassette-based or cassetteless x-ray systems. Not for use in mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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# Appendix A

#### 510( K) summary Per title 21 CFR 807.92

### CDCR 5020s,UCCR7001,TCCR7001 CR Readers - COMPUTED RADIOGRAPHY IMAGING SYSTEMS

| 1. SUBMITTER : | CR TECH LTD |
|----------------|-------------|
| | 5 Lavon St. |
| | Haifa 34951 |
| | Israel |

| 2. CONTACT PERSON : | David Hashavit |
|---------------------|----------------------------|
| | Regulatory Affairs Manager |
| | 5 Lavon St. |
| | Haifa 34951 |
| | Israel |
| Telephone: | 011 972 4 8204667 |
| Fax: | 011 972 4 8203621 |
| Email | [e-mail] |

3. Submission Date : 08 APRIL 2005

#### 4. Device Name

| Trade Names : | CDCR5020s |
|---------------|---------------------------------------------------------|
| | UCCR 7001 |
| | TCCR 7001 |
| Common Name : | Storage Phosphor reader cassette and cassetteless based |

- 5. Device Classification : Class II per CFR 892.2030 PRODUCT CODE : MQB
#### 6. PREDICATE DEVICES

The CDCR 5020s ,UCCR7001 and TCCR7001 CR READERS devices are substantially equivalent to the following predicate devices with regard to device features and specifications ,as well as intended use.

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Image /page/1/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

CR Tech, Inc. % Mr. Leonard Frier Official Correspondent MET Laboratories, Inc. 914 West Patapsco Avenue BALTIMORE MD 21230-3432

AUG 23 2013

Re: K051494

Trade/Device Name: Medical Image Digitizer, Models: CDCR 5020s, UCCR 7001 and TCCR 7001 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 8, 2005 Received: September 9, 2005

Dear Mr. Frier:

This letter corrects our substantially equivalent letter of September 21, 2005. 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely Yours,

Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510K number: K051494

Device Name: Medical Image Digitizer

Indications For Use

The CDCR5020s,UCCR7001 and TCCR7001 are intended to be used in radiological practices as laser digitizers for phosphor storage plate. The images are sent for processing to a PC.

- 1. Model CDCR 5020s This device is used on cassette based x-ray systems using the standard Buckey exist on every system. After exposing the cassette which includes the phosphor plate ,the plate is digitized and the digital image is transferred to the PC for processing
- 2. Models UCCR 7001 ,TCCR 7001

With these two devices the organ or object for x-ray exposure are positioned In the front of the device (near the phosphor plate which is positioned into the device) and after exposure the digitizing process is taking place,then the Digital image is transferred to the PC for processing.

The only difference in the models are the way of use eather Vertical for Upright or horizontal under the Radiographic Table.

ALL ABOVE MODELS ARE NOT TO BE USED FOR MAMMOGRAPHY

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Or

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Lygum

(Division Sign-Off) Division of Reproductive, Abdominal & Radiological Devices

510(k) Number KD51494

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use_