(117 days)
To be used for processing of radiographed films.
Developing exposed x-ray film.
Designed solely for processing of radiographed films, by roller transport system and by use of developer/fixer solutions(that are to be locally obtained).
The provided document is a 510(k) summary for a Radiographic Film Processor and does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it is a traditional medical device (film processor) and not an AI/ML-based device.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from this document. The document focuses on the physical characteristics, intended use, and non-clinical tests for electrical safety and performance of the film processor.
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APR 2 3 2003
Ko24342
| 510(k) Summary of “DAITO CO., LTD.”(FDA 501(k) Number: K024342) | |||
|---|---|---|---|
| (a) | |||
| (1) | Submitter's name:address:telephone no.:contact person:The date the summary was prepared: | DAITO CO., LTD.6-15-15 SANGA, DAITO-SHI, OSAKA 574-0077, JAPAN81-72-875-5171Mr. Hiroshi TanakaMarch 27/2003 | |
| (2) | The name of the device: | Radiographic Film Processor | |
| Classification name: | Automatic Radiographic Film Processor | ||
| (3) | Identification of legally marketed device: AFP Mini Med/90, AFP Mini Med | ||
| (4) | Description of the device that is the subject of the premarket notification: submission:*Designed solely for processing of radiographed films, by roller transport system and byuse of developer/fixer solutions(that are to be locally obtained).Significant physical and performance characteristics: | ||
| *Material used: | Plastic and stainless steel(common to Models XP400 & XP1000) | ||
| *Dimensions (LxWxH): | (Model XP400) | 56.5x60.0x45.0cm | |
| (Model XP1000) | 65.7x76.8x51.0cm | ||
| *Net Weight: | (Model XP400) | 30.0Kg | |
| (Model XP1000) | 58.0Kg | ||
| *Film sizes to be processed: | 10~36cm side x 91.4cm long(common to XP400/XP1000) | ||
| *Film type: | Ordinary films(sheet films)..common to XP400/XP1000 | ||
| *Chemistry type: | Ordinary one for auto-processors...common to XP400/XP1000 | ||
| *Tank capacity: | (Model XP400) | 2.0L(DEV), 2.0L(FIX), 2.0L(WASH) | |
| (Model XP1000) | 6.5L(DEV), 6.5L(FIX), 5.5L(WASH) | ||
| *Processing speed: | (Model XP400) | 3/4/5 min. selectable(dry to dry) | |
| ((Model XP1000) | 90/110/150sec.(dry to dry) | ||
| *Film processing capacity: | (Model XP400) | Max. 61 x 14"x17" film at 3 min. speed | |
| (Model XP1000) | Max. 83 x 14"x17" film at 90sec. Speed | ||
| *Water consumption: | Within 3L/min.(common to XP400/XP1000) | ||
| *Film drying method: | I.R. Heater(common to XP400/XP1000) | ||
| *Automatic standby: | Yes(common to XP400/XP1000) | ||
| *Light proof cover: | Yes(common to XP400/XP1000) | ||
| *Power source: | Single phase, 110~120V, 60Hz.(common to XP400/XP1000) | ||
| (5) | Intended use: | To be used for processing of radiographed films. |
(6) Technological characteristics: See the above (4).
(b) 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment of performance data
- (1) A brief discussion of the nonclinical tests submitted: : Both of Models XP400 & XP1000 "PASSED" JQA Tests against (1) Power Input, (2) Protective Earthing, (3) Excessive Temperatures, (4) Continuous Leakage Currents and (5) Dielectric Strength.
- The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (2) Device is as as afe, as effective, and performs as well as or better than the legally marketed Device identified in paragraph (a),(3) of this section:
This "510(k) Summary" is submitted in a separate section of the submission. (c)
- (d) Any other information reasonably deemed necessary by the agency: Not applicable.
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Image /page/1/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 image of an eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2003
Daito Co., Ltd. % Mr. Edward Epstein Jade, Ltd. 945 Main Street, Suite 312 MANCHESTER CT 06040 Re: K024342
Trade/Device Name: Radiographic Film Processors Models XP400 & EP1000 Regulation Number: 21 CFR 892.1900 Regulation Name: Automatic radiographic Film processor Regulatory Class: II Product Code: 90 IXW Dated: March 27, 2003 Received: March 31, 2003
Dear Mr. Epstein:
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.
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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. Brogdon
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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S 10(k) Number (if known): K024342
Device Name:_Daito XP400 & XP1000
Indications For Use:
Developing exposed x-ray film.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Nancy C. Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K024342 |
| Prescription Use | / |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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§ 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.