CS 7600

K111649 · Carestream Health, Inc. · MUH · Sep 23, 2011 · Dental

Device Facts

• Record ID: K111649
• Device Name: CS 7600
• Applicant: Carestream Health, Inc.
• Product Code: MUH · Dental
• Decision Date: Sep 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The CS 7600 is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and stores diagnostic intraoral radiographic images. It consists of a scanner, re-usable imaging plates, acquisition software, disposable hygienic barrier envelopes, and optional Scan & Go device.

Device Story

CS 7600 is a computed radiography system for dental intraoral imaging. System uses re-usable storage phosphor plates exposed to X-rays like traditional film. Plates are inserted into a scanner; laser scans plates to digitize image data. System automatically erases plates after scanning for reuse. Optional Scan & Go device uses RFID to identify plates. Operated by dentists/dental sub-specialists in clinical settings. Output displayed on monitor and stored on computer for diagnostic review. Benefits include digital workflow, image storage, and plate reuse.

Clinical Evidence

No clinical data. Verification and validation testing performed on software, hardware systems, media, and the complete assembled device. RFID technology tested for compliance with FCC and international rules for low power transmitters.

Technological Characteristics

Computed radiography system using storage phosphor plates (sizes 0-4). Includes laser scanner, acquisition software, and optional RFID-based Scan & Go system. Connectivity via computer interface. Verification testing confirms compliance with safety and performance requirements.

Indications for Use

Indicated for dental digital radiography using phosphor storage imaging plates for intra-oral x-ray imaging in dental patients.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Kodak CR 7400 (K060079)
• Soredex Digora Optime (K041050)

Submission Summary (Full Text)

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# 510(k) Summary CS 7600

SEP 2 3 2011

## 1. Company Identification

Carestream Health, Inc. 150 Verona Street Rochester. NY 14608 Establishment Registration: 1315356

### 2. Contact Person

Daniel Hoefer Manager, Regulatory Affairs, Carestream Dental 1765 The Exchange Atlanta, GA 30339 Tel [phone] Fax [phone]

# 3. Device Name

Commercial name: Common name: Classification name:

CS 7600 Dental Computed Radiography System Extraoral source x-ray system

# 4. Device Classification

Class: II, 21 CFR 872.1800 Product Code: MUH

### 5. Intended Use

The CS 7600 is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and stores diagnostic intraoral radiographic images. It consists of a scanner, re-usable imaging plates, acquisition software, disposable hygienic barrier envelopes, and optional Scan & Go device.

#### 6. Device Description

The CS 7600 is a computed radiography system for dental intraoral applications. Imaging plates (i.e., storage phosphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data from the plates is digitized, and the images are displayed on a monitor and saved to computer.

The CS 7600 system is capable of scanning the X-ray exposed imaging plates at various speeds, sizes and resolutions. Once an imaging plate is scanned, the image data is automatically erased from the plate and the plate ejected for reuse.

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Re-usable intraoral imaging plates of sizes 0, 1, 2, 3 and 4 are included with the device, as are disposable hygienic barrier sheaths. The system includes an optional Scan and Go system, which uses RFID technology to automatically recognize imaging plates as they are scanned.

## 7. Substantial Equivalence

The CS 7600 is substantially equivalent the Kodak CR 7400 (K060079) and the Soredex Digora Optime (K041050). Each listed device is a computed radiography device utilizing phosphor plates for dental diagnostic imaging. The devices are equivalent in terms of indications for use, operating principle and technology, energy used, and materials.

## 8. Non-Clinical testing

Verification and validation testing of the CS 7600 was performed on software, hardware systems, media, and on the complete assembled device. The RFID technology has been tested for compliance with FCC and international rules for low power transmitters.

Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.

## 9. Conclusion

The CS 7600 is substantially equivalent to the predicate devices listed above. Testing has demonstrated that it is safe and effective for its intended use.

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Public Health Service

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

Mr. Daniel Hoefer Manager. Regulatory Affairs Carestream Health, Inc. 1765 The Exchange, Inc. ATLANTA GA 30339

> Regulatorv Class: H Product Code: MUH Dated: September 8, 2011 Received: September 9, 2011

Trade/Device Name: CS 7600

Regulation Number: 21 CFR 872.1800

Regulation Name: Extraoral source x-ray svstem

Re: K111649

SEP 2 3 2011

Dear Mr. Hoefer:

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. Ilisting 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 Viro 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.hunl.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. 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

The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.

# Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

Michael D'Her

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K///649