Standard Imaging IVB 1000 Well Chamber
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- IVB 1000 EUDAMEDStandard Imaging IVB 1000 Well Chamber FDA UDI
- Generic Name
- Radiation condenser R-meter FDA UDI
- Device Name
- Well Chamber EUDAMEDStandard Imaging IVB 1000 is a medical device intended as a transducer for brachytherapy radiation QA measurements. FDA UDI
- Model / Reference
- 90009 EUDAMEDFDA UDI
- Description
- Standard Imaging IVB 1000 is a medical device intended as a transducer for brachytherapy radiation QA measurements. FDA UDI
Identifiers
- Catalog Number
- 90009 FDA UDI
- Primary DI / UDI-DI
- 00866562000250 EUDAMEDFDA UDI
- Basic UDI-DI
- 08665620002WELLCHAMBERAQ EUDAMED
- 510(k) Number
- K013548 FDA 510(k)
- FDA Product Code
- KPT FDA 510(k)FDA UDIIWJ FDA UDIJAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation condenser R-meter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1360 FDA 510(k)
- Regulation Number
- 892.1360 FDA 510(k)FDA UDI892.5650 FDA UDI892.5700 FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Standard Imaging IVB 1000 Well Chamber is a Calibrator, Dose, Radionuclide device designed for verifying the strength of brachytherapy sources. It is classified under the Radiology specialty and falls under FDA product code KPT, with a device class of II. This well chamber is engineered to accommodate multiple brachytherapy sources with lengths up to 100 mm, ensuring precise dose calibration for independent verification.
The IVB 1000 Well Chamber is supplied as a reusable device and is intended for use in radiology settings where brachytherapy source calibration is required. It has an active length four times longer than comparable models, enhancing its suitability for long source trains. Per manufacturer recommendations, the chamber should undergo recalibration every two years. Authorized under FDA 510K and MDR, it adheres to regulatory standards for dose measurement in radionuclide applications.
Frequently asked questions
What types of brachytherapy sources can the IVB 1000 Well Chamber accommodate, and why is its active length important for calibration?
The IVB 1000 Well Chamber is designed to handle brachytherapy sources with lengths up to 100 mm, making it suitable for longer source trains. Its active length is four times longer than comparable models, which enhances precision during dose calibration, especially for extended source configurations. This extended length ensures accurate verification of dose distribution for complex or multi-source brachytherapy setups.
Is the IVB 1000 Well Chamber intended for single-use or reusable applications, and what maintenance does it require?
The IVB 1000 Well Chamber is reusable and intended for long-term use in radiology settings. To maintain accuracy, the manufacturer recommends recalibration every two years, ensuring consistent dose measurement performance over time.
What regulatory pathways does the IVB 1000 Well Chamber follow, and how does this affect its use in clinical settings?
The device is authorized under FDA 510K clearance (K013548) and MDR (Medical Device Regulation), confirming compliance with U.S. and EU regulatory standards for dose calibration in radionuclide applications. This approval ensures it meets stringent safety and performance requirements for verifying brachytherapy source strength in clinical practice.
How does the IVB 1000 Well Chamber’s design benefit radiology departments handling long source trains compared to standard models?
Unlike shorter well chambers, the IVB 1000’s extended active length (four times longer) allows for precise dose calibration of longer brachytherapy source trains (up to 100 mm), reducing measurement errors in complex treatments. This is particularly useful for departments treating larger volumes or high-dose-rate applications where accuracy is critical.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IVB 1000 Well Chamber - Standard Imaging, IVB 1000 Well Chamber - Standard Imaging, PDF Ivb1000 Well Chamber
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K013548 | Class II | Active |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (3)
- FDA 510(k) K013548 24 fields · synced Sep 18, 2026
- FDA UDI cfaca002-39a5-49c5-a2bd-0c8fac26b38c 34 fields · synced May 30, 2026
- EUDAMED d63b62f2-742e-4e69-85b6-f55467ab6ec1 61 fields · synced Aug 1, 2026