(30 days)
Not Found
Not Found
No
The device is a passive cassette for holding a storage phosphor screen and does not involve any processing or analysis of data.
No
The device is a cassette for holding a storage phosphor screen for recording a patient radiation pattern; it is not described as treating, preventing, or diagnosing a disease or condition.
No
Explanation: The device is a cassette designed to hold a storage phosphor screen for recording patient radiation patterns. It is an accessory to radiographic equipment, not the diagnostic device itself which would read or interpret the pattern.
No
The device description clearly states it is a physical cassette for holding a storage phosphor screen, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device function: The KODAK DirectView Tabletop CR Cassette is a container for a storage phosphor screen used in radiography. Its purpose is to hold the screen during exposure to radiation from a patient, allowing a radiation pattern to be recorded.
- No specimen analysis: The device itself does not analyze any biological specimens. It is part of the imaging process, not a diagnostic test performed on samples taken from the body.
The device is a component of a radiographic imaging system, which is used for diagnostic purposes, but the cassette itself is not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
90 IXA
Device Description
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 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.
Mentions image processing
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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.
2
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.
3
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 | (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 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 (800) 638-2041 or (301) 443-6597 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 |
|---|---|
| --------------- | --------- |