Nuclear Patient Sanning Tables, Various Types
FDA 510(k) K926083 · Biodan Medical Systems, Ltd.
510(k) numberK926083
Submission
- Device name
- Nuclear Patient Sanning Tables, Various Types
- Applicant
- Biodan Medical Systems, Ltd.
Shirley, NY, US - Received
- December 1, 1992
- Decision date
- February 12, 1993
- 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 |
| K212587 | 3D-RD-SIYX · Traditional | Radiopharmaceutical Imaging and Dosimetry, LLC | 02/22/2023SE |
| 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 |
More from General Equipment For Medical Imaging, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K932153 | Thyroid Uptake System & Atomlab 950 Med. SpectromeIZD · Traditional | 09/07/1993SE |
| K930261 | RTM Rehabilitation Treadmill, Model #945-200IOL · Traditional | 05/26/1993SE |
| K930262 | Treatment Table, Model #825-100INO · Traditional | 03/29/1993SE |
| K930259 | Traction Table Model #825-200JFB · Traditional | 03/24/1993SE |
| K926082 | Cardiac Stress Table, 056-180/UNIV Roll Stress AttIZI · Traditional | 12/30/1992SE |
| K922591 | Urological C-Arm Table, Model #056-450IXR · Traditional | 11/27/1992SE |
| K922605 | Trendelenburg Ultrasound Table, Model # 056-603IYO · Traditional | 10/20/1992SE |
| K922604 | Deluxe Adjustable Height Ultrasound TableIYO · Traditional | 10/20/1992SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | 07/23/1992SE |
| K922772 | Two Position Roll-Up Back Attachment ChairIKK · Traditional | 07/13/1992SE |
Questions and answers
When was Nuclear Patient Sanning Tables, Various Types cleared by the FDA?
Nuclear Patient Sanning Tables, Various Types (K926083) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 73 days after the submission was received.
What is the product code of K926083?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.