(140 days)
No
The summary describes a shielded cabinet x-ray radiation source for blood irradiation, with no mention of AI, ML, image processing, or data analysis that would typically indicate the presence of such technology.
No.
The device is described as an X-ray Radiation Source intended for the irradiation of blood or blood products, which is a treatment modality, not a diagnostic one.
No
Explanation: The device is described as an X-ray radiation source intended for the irradiation of blood products. Its purpose is therapeutic (reducing the risk of Graft Versus Host Disease) rather than diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it consists of a shielded enclosure, x-ray tubes, power supply, and controller, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the irradiation of blood or blood products packaged in transfusion bags to reduce the risk of Graft Versus Host Disease. This is a therapeutic or preventative treatment applied to a biological product outside the body, not a diagnostic test performed on a sample to determine a medical condition.
- Device Description: The device is a shielded cabinet containing X-ray tubes for irradiation. This aligns with a treatment or processing device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The RS 3000 Shielded Cabinet X-ray Radiation Source is intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Reqarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.
Product codes
90 MOT
Device Description
The RS 3000 Shielded Cabinet X-ray Radiation Source consists of A shielded enclosure containing 2 vertically opposed x-ray tubes with provision for a sample holder (canister) between them, a power supply and a controller.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows a logo for "RAD-SOURCE". The logo features the word "RAD" stacked on top of the word "SOURCE". There are two triangles on the left and right side of the text. There are also several horizontal lines on the right side of the text.
MAR 3 0 100
510 (k) Summary as required by 807.92 (c) for the RS 3000 Shielded Cabinet X-ray Radiation Source Prepared November 6, 1997
Rad-Source, Inc.. Submitted by: 475 Ramblewood Dr. #207 Coral Springs, Florida 33071 Tel. 954 755-0328
Randol E. Kirk Contact Person: President
- Device Trade Name:
ﺴﯿﺴﺎ
RS 3000 Shielded Cabinet X-ray Radiation Source.
- blood irradiator. Common Name:
- not classified. Classification:
- IBL 437C (K865027) manufactured by Predicate Device: CIS-US, Inc. 10 DeAngelo Drive Bedford, Massachusetts 01730
Description of Device:
The RS 3000 Shielded Cabinet X-ray Radiation Source consists of A shielded enclosure containing 2 vertically opposed x-ray tubes with provision for a sample holder (canister) between them, a power supply and a controller. (Brief physical description of the device and its function)
Intended Use of Device:
The RS 3000 Shielded Cabinet X-ray Radiation Source is intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Reqarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.
475 Ramblewood Dr #207 Coral Springs F1 33071 (954) 755 0328
1
Image /page/1/Picture/0 description: The image shows a logo for "RAD SOURCE". The logo features the text "RAD SOURCE" in a bold, sans-serif font. The word "RAD" is on the left, and the word "SOURCE" is on the right. There are two black triangles, one above and one below the text, pointing towards the center. There are also horizontal lines above and below the text, creating a visual effect of radiation.
Substantial Equivalence to Predicate Device:
The RS 3000 Shielded Cabinet X-ray Radiation Source is substantially equivalent to the IBL 437C Blood Irradiator (K865027). Both are indicated for the irradiation of blood and blood products to reduce the risk of transfusionassociated graft-versus-host disease in recipients at risk of this complication. The significant clinical characteristics of the two devices are compared below.
| RS 3000 | IBL 437C | |
|---|---|---|
| Source: | 160 kVdc x-rays | |
| .38 mm Cu filter | ||
| hvl app. 4 cm H₂0 | Cs-137, 662 keV | |
| Dose rate: | 3 Gy min⁻¹. | > 4 Gy min⁻¹ |
| Max/min dose ratio: |