Identity
- Trade Name
- Sirius MRI Marker NS FDA UDI
- Generic Name
- Brachytherapy source spacer FDA UDI
- Device Name
- The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy. FDA UDI
- Model / Reference
- F-01-01-0011 FDA UDI
- Description
- The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863593000228 FDA UDI
- 510(k) Number
- FDA Product Code
- KXK FDA 510(k)FDA UDI
- GMDN Term
- Brachytherapy source spacer FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5730 FDA 510(k)
- Regulation Number
- 892.5730 FDA 510(k)FDA UDI
- 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Sirius MRI Marker NS by C4 Imaging, LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171487 | Class II | Active |
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Manufacturer
- Manufacturer
- C4 Imaging, LLC
Sources (2)
- FDA 510(k) K171487 24 fields · synced Jun 18, 2026
- FDA UDI c399f0e4-5aed-4361-afdf-a94b93c66e12 34 fields · synced May 26, 2026