(90 days)
Not Found
Not Found
No
The description focuses on the mechanical and chemical processes of film development, with no mention of AI or ML. The "micro-processor" is used for adjusting processing conditions, which is a standard control system function, not indicative of AI/ML.
No
The device is an automatic radiographic film processor, which processes films for medical imaging but does not directly treat or diagnose a medical condition.
No
The device is an automatic radiographic film processor, which processes films exposed for medical purposes. It does not perform a diagnostic function but rather processes the output required for diagnosis by a medical professional.
No
The device description clearly details a physical machine with a roller transport system, temperature-regulated solutions, and a feed width, indicating it is a hardware device for processing radiographic film.
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 is a process that happens after the diagnostic image is captured, and it's related to the physical development of the film, not the analysis of biological samples or substances from the human body.
- Device Description: The description focuses on the mechanical and chemical processes involved in developing, fixing, washing, and drying radiographic film. It describes a physical process applied to a physical medium (film).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that definition.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
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 1000 is 35cm, the smallest film format of the processor is 10x10cm.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
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): 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.
Protec Optimax Automatic X-Ray Film Processor
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
§ 892.1900 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
KO23801
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
FEB 1 2 2003
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 1000
Common Name: Automatic Radiographic Film Processor
Classification Name: Automatic Radiographic Film Processor
Regulation Number: 892.1900
Product Code: IXW
Predicate Device
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 1000 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 1000 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 ejected 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
FEB 1 2 2003
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 Re: K023801 Trade/Device Name: Film Processor, Life Ray Pro 1000 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) 638-2041 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 1000.
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).
1 Prescription Use (Per 21 CFR 801.109)
Daniel A. Legum
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number