(90 days)
OPTIMAX K992818
No
The description details a traditional film processing device with a microprocessor for adjusting settings, but no mention of AI or ML for image analysis or other functions.
No
The device is an automatic radiographic film processor, which is used for processing medical films, not for diagnosing, treating, or preventing disease.
No
Explanation: The device is an automatic radiographic film processor, which processes films for medical purposes. It is not used to diagnose conditions directly but rather to prepare images for diagnostic interpretation.
No
The device description clearly details a physical machine with mechanical components (roller transport system, film registration, transport system, drying mechanism) and chemical processes (developing, fixing, washing). This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to process films exposed for medical purposes, specifically for radiographic and diagnostic imaging procedures. This involves processing physical films after they have been exposed to radiation, which is a step in the imaging workflow, not a test performed on biological samples in vitro.
- Device Description: The description details the mechanical and chemical process of developing, fixing, washing, and drying films. This is a physical process applied to a film medium, not a diagnostic test performed on a patient's sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to process the output of a medical imaging procedure (the exposed film), not to perform a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and dryng of films. The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures.
Product codes
IXW
Device Description
Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperatureregulated, circulated and automatically replenished. The feed with of the LifeRay PRO 2500 is 35cm, the smallest film format of the processor is 10x10cm.
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
Typical users of this system are trained medical professionals, including but not limited to physicians. nurses, and lab technicians.
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)
OPTIMAX K992818
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
510(k) Safety and Effectiveness Summary.
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a)
Submitter Information
FERRANIA USA INC., Official Corrispondent Ferrania Imaging Technologies 2700-EAST FRONTAGE ROAD WEATHERFORD, OK 73096 Phone: (580) 774-3623 Fax: (580) 774-3658 Contact Person: Mr Doug Hale
S.a.i.e.p. S.r.l., Manufacturer Via Stalingrado 4/32 17014 Cairo Montenotte - GENOVA - ITALY Phone: 0039 019 506108 Fax: 0039 019 5091323 Contact Person: Mario Daniel
Date: 2002-10-29
| Trade Name: | LIFERAY PRO 2500 |
|---|---|
| Common Name: | Automatic Radiographic Film Processor |
| Classification Name: | Automatic Radiographic Film Processor |
Regulation Number: 892.1900
Product Code: IXW
Predicate Device
Protec Medizintecnick OPTIMAX K992818
Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table
1
· Device Description:
Due to the precise roller transport system, both sheet and roller films can be processed. The Automatic film registration is activated immediately when a film is fed in. The transport system starts running. The film material is developed , fixed, rinsed and dried. With the easy to operate micro-processor, the processing conditions can be adjusted to suit the various film and chemical types. The developing solutions are temperatureregulated, circulated and automatically replenished. The feed with of the LifeRay PRO 2500 is 35cm, the smallest film format of the processor is 10x10cm.
• Intended Use:
The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and dryng of films.
Summary of Substantial Equivalence Comparison: .
The comparison of similarities and differences shows that the new device LifeRay PRO 2500 Automatic Radiographic Film Processor, which is intended to market and the predicate device:
-
- Have the same intended use.
-
- Have the same target user group.
-
- Have the same technological characteristics.
There are no new questions about safety and effectiveness. The new device is a safe and effective as the predicate device.
The Automatic Radiographic Film Processor is substantially equivalent to the Protec Optimax Automatic X-Ray Film Processor.
· Technological Characteristics:
The photographic processing (developing) technique employed by the Automatic Radiographic Film Processor is the same as the predicate device. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then eiected for viewing. The processors use mechanical rollers and guides for transportation, the solutions are temperature-regulated, circulated and automatically replenished, and same additional functions (anti-crystallization cycle, stand-by mode). Both are controlled by an integrated software.
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
S.A.I.E.P. S.r.1. % Mr. Mario Daniel Ferrania USA, Inc. Ferrania Imaging Technologies 2700 East Frontage Road WEATHERFORD OK 73096-6104 FEB 1 2 2003
Re: K023825
Trade/Device Name: LifeRay PRO 2500 Regulation Number: 21 CFR 892.1900 Regulation Name: Automatic radiographic film processor Regulatory Class: II Product Code: 90 IXW
Dated: October 29, 2002 Received: November 14, 2002
Dear Mr. Daniel:
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 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) 633-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for use.
Applicant:
510(k) Number (if known): _
Device Name: Automatic Radiographic Film Processor LifeRay PRO 2500.
Indication For Use: The Automatic Radiographic Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures. Typical users of this system are trained medical professionals, including but not limited to physicians. nurses, and lab technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Prescription Use
David a. Segner
Section 10