(87 days)
Not Found
Not Found
No
The summary describes a film processor, a traditional device for developing X-ray film, and contains no mention of AI, ML, or advanced image processing techniques typically associated with AI/ML in medical imaging.
No.
The device is an X-Ray Film Processor, which is used for developing X-ray films, not for direct therapeutic intervention on a patient.
No
The device, an X-Ray Film Processor, processes X-ray film. It does not perform any diagnostic function such as identifying disease or providing information about a medical condition.
No
The device description explicitly states "SRX-701 Film Processor," which is a hardware device used for developing X-ray film. The intended use also refers to "X-Ray Film Development," a process performed by hardware. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "X-Ray Film Development". This is a process that prepares an image for viewing, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is an "SRX-701 Film Processor". This further supports its role in image processing, not diagnostic testing.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Reagents or kits typically associated with IVD tests
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. An X-ray film processor simply develops the image captured by an X-ray machine.
N/A
Intended Use / Indications for Use
X-Ray Film Development
Product codes (comma separated list FDA assigned to the subject device)
90 IXW
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-Ray
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
§ 892.1900 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
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 18 1999
Konica Medical Corporation ATTN: Russell D. Munves C/O Storch, Amini & Munves, P.C. The Chrysler Building 405 Lexington Avenue New York. New York 10174
RE: K990969
Konika SRX 701 Automatic X-ray Film Processor Dated: March 22, 1999 Received: March 23, 1999 Regulatory Class: II 21 CFR 892.1900/Procode: 90 IXW
Dear Mr. Munves:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, 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 dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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 (if known):_
Device Name:__SRX-701 Film Processor
Indications For Use: X-Ray Film Development
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ..
Concurrence of CDRH, Office of Device Evaluation (ODE)
Uhind G. Segen
(Division Sign-Off)
።
Division of Reproductive, Abdominal, ENT, and Radiological Devig 510(k) Number
Prescription Use_L (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)