(90 days)
None
No
The description focuses on the mechanical and chemical processes of film processing, with temperature control managed by a standard computer board. There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is described as a diagnostic device used to process X-ray film, and its sole purpose is to develop, fix, wash, and dry films for medical and dental purposes. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes."
No
The device description clearly states it is an "Automatic Radiographic Film Processor" that uses physical components like "transport rollers," "developer solution," "fixer solution," and "wash water tanks." It also mentions a "computer board" controlling temperature, but the core function involves physical processing of film, not just software.
Based on the provided information, the Level 356 X-Ray Film Processor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Level 356 X-Ray Film Processor processes radiographic film that has been exposed for medical and dental purposes. This film contains an image created by X-rays passing through the body. The processing is a step in creating a diagnostic image, but the device itself is not analyzing a biological sample in vitro.
- Intended Use: The intended use clearly states it's a "diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes." This describes a process applied to a physical medium (film) that holds diagnostic information, not a test performed on a biological sample.
Therefore, the Level 356 X-Ray Film Processor is a device used in the process of creating diagnostic images, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Level 356 X-Ray Film Processor is a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.
Product codes
90 IXW
Device Description
Automatic Radiographic Film Processor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(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
Fischer Industries Inc.®
2630 Kaneville Court, Geneva, IL 60134
(630) 232-2803 • Fax (630) 232-2875 www.fischerind.com
Section B – 510(K) Summary
| Submitted by: | Fischer Industries, Inc.
2630 Kaneville Court
Geneva, IL 60134
Telephone: (630) 232-2803
Fax: (630) 232-2875 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Phil O'Keefe |
| Date Submitted: | 6/11/02 |
| Trade Name of this Device: | Level 356 X-Ray Film Processor |
| Common or Useful Name: | Film Processor |
| Classification Name: | Automatic Radiographic Film Processor |
| Substantial Equivalence: | Futura System 30 DX
K940112
4/11/95 |
| Description of Device: | Automatic Radiographic Film Processor |
| Intended Use: | The Level 356 X-Ray Film Processor is a
diagnostic device intended to be used to
develop, fix, wash, and dry automatically
and continuously film exposed for medical
and dental purposes. This is the sole purpose
of this device. |
| Comparison Summary: | This film processor is operates like most
predicate devices in that it uses a series of
transport rollers to pull film through a series
of open developer solution, fixer solution,
and wash water tanks. Developer and fixer
solution temperature is controlled
automatically by a computer board. No
plumbing is required |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2002
Mr. Philip J. O'Keefe Director of Engineering Fischer Industries, Inc. 2630 Kaneville Court GENEVA IL 60134
Re: K022154
Trade/Device Name: Level 356 X-Ray Film Processor Models MD and MD-D Regulation Number: 21 CFR $892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: 90 IXW Dated: June 27, 2002 Received: July 2, 2002
Dear Mr. O'Keefe:
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.
2
Page 2
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 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 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 by reference to premarket 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 Crozdon
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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Page__1__of 1
510(k) Number (il known): K022154
Ocvice Name:Level 356 X-Ray Film Processor, Models MD & MD-D
Indications For Use: The Level 356 X-Ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to develope, fix, wash, and dry automatically and continuously film exposed for medical and dental purposes. This is the sole purpose of this device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER P/ NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022154
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Formal