3D-RD-S
FDA 510(k) K212587 · Radiopharmaceutical Imaging and Dosimetry, LLC
510(k) numberK212587
Submission
- Device name
- 3D-RD-S
- Applicant
- Radiopharmaceutical Imaging and Dosimetry, LLC
Baltimore, MD, US - Received
- August 16, 2021
- Decision date
- February 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)IYX · Traditional | Versant Medical Physics and Radiation Safety | 08/28/2023SE |
| K163687 | Olinda ExmIYX · Traditional | Hermes Medical Solutions AB | 07/19/2017SE |
| K160933 | Discovery NM 750b BopsyIYX · Traditional | GE Healthcare | 11/18/2016SE |
| K162052 | Sentinella 102, Sentinella 102 HorusIYX · Special | General Equipment For Medical Imaging (Oncovision- | 08/18/2016SE |
| K143156 | Sentinella 102; Sentinella 102 HorusIYX · Traditional | General Equipment For Medical Imaging (Oncovision- | 11/18/2014SE |
| K123408 | Ergo Imaging SystemIYX · Traditional | Digirad Corp. | 01/15/2013SE |
| K111791 | Lumagem Molecular Breast Imaging SystemIYX · Traditional | Gamma Medica-Ideas Incorporated | 09/23/2011SE |
| K110384 | Dilon 6800 Acella (Acella)IYX · Traditional | Dilon Technologies, Inc. | 05/03/2011SE |
| K110601 | Sentinella 102IYX · Traditional | General Equipment For Medical Imaging, S.A. | 03/18/2011SE |
| K102231 | Discovery NM 750BIYX · Traditional | Ge Medical Systems Israel, Functional Imaging | 11/03/2010SE |
Questions and answers
When was 3D-RD-S cleared by the FDA?
3D-RD-S (K212587) received a 510(k) decision of Substantially Equivalent on February 22, 2023, 555 days after the submission was received.
What is the product code of K212587?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.