Handheld Gamma Finder (HGF)
FDA 510(k) K013751 · Silicon Instruments Gmhb
510(k) numberK013751
Submission
- Device name
- Handheld Gamma Finder (HGF)
- Applicant
- Silicon Instruments Gmhb
Berlin, DE - Received
- November 13, 2001
- Decision date
- February 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IZD
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|---|---|---|---|
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| K101887 | Confident Surgery Suite 300, Model CSS300IZD · Traditional | Surgiceye GmbH | 03/22/2011SE |
| K983768 | Modification to Gamma Guidance SystemIZD · Traditional | Radiation Monitoring Devices, Inc. | 07/02/1999SE |
| K982442 | C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)IZD · Traditional | Care Wise Medical Products Corp. | 08/25/1998SE |
| K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesIZD · Traditional | Neoprobe Corp. | 06/26/1997SE |
| K961321 | Gamma Guidance SystemIZD · Traditional | Radiation Monitoring Devices, Inc. | 02/10/1997SE |
| K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesIZD · Traditional | Neoprobe Corp. | 09/13/1996SE |
| K942580 | Neoprobe 1000 Portable Radioisotope Detector and AccessoriesIZD · Traditional | Neoprobe Corp. | 02/09/1995SE |
| K932153 | Thyroid Uptake System & Atomlab 950 Med. SpectromeIZD · Traditional | Biodan Medical Systems, Ltd. | 09/07/1993SE |
Questions and answers
When was Handheld Gamma Finder (HGF) cleared by the FDA?
Handheld Gamma Finder (HGF) (K013751) received a 510(k) decision of Substantially Equivalent on February 6, 2002, 85 days after the submission was received.
What is the product code of K013751?
The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.