KODAK DIRECTVIEW TABLETOP CASSETTE

K013686 · Eastman Kodak Company · IXA · Dec 7, 2001 · Radiology

Device Facts

• Record ID: K013686
• Device Name: KODAK DIRECTVIEW TABLETOP CASSETTE
• Applicant: Eastman Kodak Company
• Product Code: IXA · Radiology
• Decision Date: Dec 7, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1850
• Device Class: Class 2

Intended Use

KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen so the screen can be exposed by radiographic equipment for the recording of a patient radiation pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.

Device Story

Device is a modified standard X-ray diagnostic cassette; holds storage phosphor screen for radiographic imaging. Modification involves replacing two intensifying screens with two black polycarbonate sheets mounted on foam to constrain and secure the phosphor screen. Used in clinical radiography; operated by radiology technicians or clinicians. Cassette exposed to X-rays to record patient radiation pattern; screen subsequently removed and processed in a laser phosphor digitizer. Output is a latent image on the phosphor screen, which is digitized for clinical diagnostic review. Benefits include enabling computed radiography (CR) workflows using existing radiographic equipment.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: black polycarbonate sheets, foam. Dimensions: standard X-ray diagnostic cassette form factor. Standards: CEI IEC 60406 Ed. 3.0:1997 (radiographic/mammographic cassettes), ISO 4090 (film dimensions). Principle: passive storage phosphor screen holder. Energy source: none (passive). Connectivity: none. Sterilization: not applicable.

Indications for Use

Indicated for use as a radiographic cassette to hold a storage phosphor screen during exposure by radiographic equipment for the recording of a patient radiation pattern in a clinical setting.

Regulatory Classification

Identification

A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

Special Controls

*Classification.* Class II (special controls). 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

• Eastman Kodak Company computed radiography system cassettes
• Fuji Medical Systems USA computed radiography system cassettes
• Agfa Medical Imaging computed radiography system cassettes

Submission Summary (Full Text)

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DEC 0 7 2001

# Attachment 7 - 510(k) Summary

KO13686

# 1. Company Identification

Eastman Kodak Company Health Imaging Division 1669 Lake Avenue Rochester, NY 14652 Establishment Registration: 1317267

#### 2. Official Correspondent

Judith A Wallace Regulatory Affairs 716 724-6111

#### 3. Device Name

KODAK DirectView Tabletop CR Cassette Trade Name:

Common Name: Storage Phosphor Cassette

## 4. Device Classification

Class II

#### 5. Applicable Standards

CEI IEC 60406 Ed. 3.0:1997 Cassettes for medical X-ray diagnosis – Radiographic cassettes and mammographic cassettes

ISO 4090 Photography – Film dimensions – Medical radiography

#### 6. Intended Medical Use:

KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen so the screen can be exposed by radiographic equipment for the recording of a patient radiation pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.

## 7. Description of Device:

The device is a cassette for holding a storage phosphor screen. It is a standard x-ray diagnostic cassette used for film screen radiography that has been modified as follows. In

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place of the two intensifying screens two pieces of black polycarbonate sheet are mounted on the foam presently used in the X-Omat Cassette. The storage phosphor screens is constrained by the film pocket of the cassette and held in place by the two plastic sheets when the cassette is closed.

#### 8. Substantial Equivalence

The Kodak DirectView Tabletop CR cassette is basically a standard, screen-film diagnostic cassette that has been adapted to hold a storage phosphor screen. This device is identical in function and thus substantially equivalent to the cassettes associated with computed radiography systems marketed by Eastman Kodak Company, Fuji Medical Systems USA and Agfa Medical Imaging.

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle's head and neck. The eagle is facing to the right, and its feathers are represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Ms. Judith A. Wallace Regulatory Affairs Manager Health Imaging Division Eastman Kodak Co. 1669 Lake Ave. ROCHESTER NY 14652

Re: K013686

Trade/Device Name: Kodak DirectView Tabletop Cassetto Storage Phosphor Cassette Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film cassette Regulatory Class: II Product Code: 90 IXA Dated: November 2, 2001 Received: November 7, 2001

Dear Ms. Wallace:

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 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.

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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 nothloadon. The PDF 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 11 you done 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 Other or Cottpremarket 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. Snigdon

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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# Attachment 5 – Indications for Use

510(K) Number (if known):

Device Name: KODAK DirectView Tabletop CR Cassette

Indication of use: KODAK DirectView Tabletop CR Cassette holds a Storage Phosphor screen Indication of use: KODAK Difect Vicw Tableop of other recording of a patient radiation
so the screen can be exposed by radiographic equipment read in a see phosphor so the screen can oc exposed by factograpme organism
pattern. The screen is removed from the cassette and the pattern read in a laser phosphor digitizer.

Concurrence of CDRH, Office of Device Evaluation

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---------------------------------------|---|
|---------------------------------------|---|

OR

| Over-The-Counter | _____ |
|------------------|-------|
|------------------|-------|

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

| 510(k) Number | K013686 |
|---------------|---------|
|---------------|---------|