(245 days)
Not Found
Not Found
Unknown
The provided 510(k) summary is completely empty, offering no information to determine if AI/ML is incorporated.
No
The provided information does not contain any details about the device's function or intended use, so it's impossible to determine if it's therapeutic.
No
The provided information is all "Not Found," so there is no data to indicate whether this device is diagnostic.
Unknown
The provided 510(k) summary is completely empty, offering no information about the device's nature, description, or intended use, making it impossible to determine if it is software-only.
Based on the information provided, it is impossible to determine if this device is an IVD (In Vitro Diagnostic).
The document contains "Not Found" for all the key sections that would typically describe a medical device, including its intended use, description, and any information about its function or how it interacts with biological samples.
An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. Without any information about the device's intended use or how it operates, we cannot classify it as an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.4010 General purpose reagent.
(a) A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g.,
Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/0 description: The image contains text in a non-English language, possibly Khmer, given the characters present. The text appears to be isolated words or phrases, with some spacing and formatting. Due to the lack of context and the language barrier, a more detailed description is not possible. The text is presented against a dark background.
)
ﺮ
1
| t1 | r | |
|---|---|---|
| . . | 1.5 | |
| 1 | ||
| 1 | ﺖ | |
| 1 | ||
| 111I | 1 | … |
| P r - | ||
| ﺴ ﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﺸ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ، ﺍﻟﺼﺤﻴﻔ | ||
| 11 11 | ||
| r "- H | ||
| ् सर | ||
| 11 TE में में ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ー . . な | |
| ﺎﺕ |
2
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------l | |
|---|---|
| ーli t | |
| र र | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 | |
| 1 = 1 | |
| les de | |
| ﺎ ﺍﻟﻤﺤﺎﻓﻈﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | |
| ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ a de la compressional de la comenta de la comenta de la comenta de la comenta de la comenta de la comenta de la comenta de la comenta de la comenta de la considera de la come |