← Product Code MOT · K974210 # SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (K974210) _Rad-Source, Inc. · MOT · Mar 30, 1998 · RA · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K974210 ## Device Facts - **Applicant:** Rad-Source, Inc. - **Product Code:** MOT - **Decision Date:** Mar 30, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** RA - **Attributes:** Therapeutic ## 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 Regarding 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. ## Device Story RS 3000 is a shielded cabinet X-ray system for blood irradiation. Device consists of a shielded enclosure, two vertically opposed X-ray tubes, a sample holder (canister), power supply, and controller. It functions by exposing blood products to X-ray radiation to prevent graft-versus-host disease. Unlike isotope-based irradiators, this system uses an X-ray source. It is intended for use in clinical or blood bank settings. Operators place blood bags into the fixed sample holder; the system delivers a controlled dose of radiation. The output is a treated blood product suitable for transfusion. The device provides a non-radioactive alternative to traditional gamma-ray sources, eliminating the need for NRC licensing and specialized radioactive material handling. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technical performance comparisons and intended use. ## Technological Characteristics Shielded cabinet X-ray system; 160 kVdc X-ray source; 0.38 mm Cu filter; dose rate 3 Gy/min; max/min dose ratio < 1.3; fixed sample holder; lead (Pb) shielding; safety interlocks; complies with 21 CFR 1020.40. ## Predicate Devices - IBL 437C ([K865027](/device/K865027.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. K974210 ## 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: | < 1.3 | < 1.67 | | Sample holder: | fixed, presents maximum
width, minimum depth | rotates in beam | | Radiation safety: | Pb shielding, interlocks | Pb shielding, interlocks | | Federal Regulatory
Environment: | Requires 510(k).
Must comply with 21 CFR
1020.40 | Requires 510(k), user must
have NRC license and
radiation safety officer,
operators must be film-
badged. | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 30 1998 Ronald E. Kirk Rad-Source, Inc. 475 Ramblewood Drive, Suite 207 Coral Spring, FL 33071 Re: K974210 RS 3000 Shielded Cabinet X-Ray Radiation Source (Blood Irradiator) Dated: February 18, 1998 Received: February 20, 1998 Unclassified Procode: 90 MOT Dear Mr. Kirk: 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 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 Counctic Act (Act). 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 (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 ecuivalent determination assumes 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 regulatory 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 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 (2) 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/cdr.idsmamain.html". Sincerely yours, Kilian Yi Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use (For Indications for Use Statement and Section 8 of Premarket Submission Cover Letter) 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 Regarding 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. Daniel le. Simpson (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/device/K974210](https://fda.innolitics.com/device/K974210) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com