(97 days)
No
The document describes a standard computed radiography cassette and scanner system, with no mention of AI or ML in the device description, intended use, or image processing.
No
The device is a cassette and storage phosphor screen used for recording patient radiation patterns from radiographic equipment; it does not treat or alleviate a disease or condition.
No
The device is a cassette and storage phosphor screen used for recording patient radiation patterns in general radiology and dental panoramic radiography. While it's used in conjunction with equipment that produces diagnostic images, the cassette itself is a component for image acquisition, not for diagnostically interpreting or analyzing the images.
No
The device description clearly details physical hardware components (cassette, storage phosphor screen, panels made of aluminum, polypropylene, carbon fiber, etc.) and its function as a physical holder for a storage phosphor screen used with radiographic equipment. While it mentions image processing software, the device itself is a physical cassette system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that the KODAK DirectView CR cassette is used to hold a storage phosphor screen that is exposed by radiographic equipment to record a patient radiation pattern. This is a component of a medical imaging system used for capturing X-ray images of the body, not for analyzing samples from the body.
- Intended Use: The intended use is for "general radiology and dental panoramic radiography applications," which are imaging procedures.
- Device Description: The description details the physical components of the cassette and screen, and how it interacts with X-ray equipment and a laser scanner to create a digital image. There is no mention of analyzing biological samples.
Therefore, the function and intended use of this device fall under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.
Product codes
90 IXA
Device Description
The Kodak DirectView CR 15 x 30 cm cassette size is designed to perform general radiography and panoramic dental exams when used with the Kodak DirectView CR 850 and CR 950 systems. The cassette system (cassette and storage phosphor screen adhered to the cassette plate) can be used in common dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography.
The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.
The image processing software algorithm will not be modified for the CR 15 x 30 cm cassette, and remains the same as the image processing software previously cleared for Kodak DirectView CR 800 and CR 900 Systems (K020635, March 21, 2002).
Mentions image processing
The image processing software algorithm will not be modified for the CR 15 x 30 cm cassette, and remains the same as the image processing software previously cleared for Kodak DirectView CR 800 and CR 900 Systems (K020635, March 21, 2002).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic equipment
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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1850 Radiographic film cassette.
(a)
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.(b)
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.
0
510(k) Summary
KO40373
1. Company Identification
Eastman Kodak Company 343 State Street Rochester, NY 14650
Establishment Registration: 1317267
2. Contact Person
Susan Pate Regulatory Affairs Associate (716)-724-4302
3. 510(k) Summary Preparation Date
02/12/2004
4. Device Name
Trade Name: KODAK DIRECTVIEW CR Cassette / GP / 15 x 30 cm
Common Name: CR 15 x 30 cm Cassette
5. Device Classification
Class II
6. Indications for Use
The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.
7. Description of Device
The Kodak DirectView CR 15 x 30 cm cassette size is designed to perform general radiography and panoramic dental exams when used with the Kodak DirectView CR 850 and CR 950 systems. The cassette system (cassette and storage phosphor screen adhered to the cassette plate) can be used in common
1
dental panoramic x-ray dental units designed to accept cassettes that meet the ISO 4090 standard. The CR cassette is a standard x-ray diagnostic cassette used for computed radiography.
The panel materials are consistent with the current design of the CR cassette and include Corus Hylite and Toray Panel. The Corus Hylite panel includes two lavers of aluminum, with polypropylene (plastic) in the middle, and is covered with Omnova (clear viny) with printing on the second surface). On the tube side of the cassette there is Toray Carbon Fiber Panel that consists of four layers of carbon fiber. The storage phosphor plate is attached to the honeycomb panel. The lead mylar that is in place under the phosphor layer of the screen was removed in the CR 15 x 30 cm cassette in order to accommodate Automatic Exposure Control (AEC) in dental x-ray units.
The image processing software algorithm will not be modified for the CR 15 x 30 cm cassette, and remains the same as the image processing software previously cleared for Kodak DirectView CR 800 and CR 900 Systems (K020635, March 21, 2002).
8. Substantial Equivalence
The KODAK DirectView CR 15 x 30 cm cassette is substantially equivalent to the Kodak Ektascan SP Cassette (K925997), previously cleared on Dcccmber 17, 1992. The Kodak Ektascan SP Cassette is currently marketed as the Kodak DirectView CR Cassette. The new cassette size is identical in function and performance to the currently marketed Kodak DirectView CR cassette.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2004
Ms. Susan M. Patc Regulatory Affairs Associate Health Imaging Division Eastman Kodak Company 343 State Street ROCHESTER NY 14650
Re: K040378 Trade/Device Name: KODAK DirectView CR Cassette/GP/15x30 cm Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film/cassette changer Regulatory Class: II Product Code: 90 IXA Dated: February 13, 2004 Received: March 16, 2004
Dear Ms. Pate:
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 111 (PMA), it may be subject to such 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 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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. Brydon
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 1 - Intended Use and Indications for Use
510(k) Number(s) (if known):
510(k) Number(s) (if known):
Device Name: KODAK DirectVicw CR Cassette / GP / 15 x 30 cm
:
Indications of Use:
The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.
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 | K040378 |