Neoprobe Portable Radioisotope Detector
FDA 510(k) K864263 · Neoprobe Corp.
510(k) numberK864263
Submission
- Device name
- Neoprobe Portable Radioisotope Detector
- Applicant
- Neoprobe Corp.
Columbus, OH, US - Received
- October 29, 1986
- Decision date
- December 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K101887 | Confident Surgery Suite 300, Model CSS300IZD · Traditional | Surgiceye GmbH | 03/22/2011SE |
| K013751 | Handheld Gamma Finder (HGF)IZD · Traditional | Silicon Instruments Gmhb | 02/06/2002SE |
| 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 |
More from Neoprobe Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K050088 | Quantix/Or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerDPW · Special | 02/08/2005SE |
| K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesIZD · Traditional | 06/26/1997SE |
| K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesIZD · Traditional | 09/13/1996SE |
| K942580 | Neoprobe 1000 Portable Radioisotope Detector and AccessoriesIZD · Traditional | 02/09/1995SE |
| K915279 | Neoprobe Portable Radioscope DetectorIZD · Traditional | 06/10/1992SE |
Questions and answers
When was Neoprobe Portable Radioisotope Detector cleared by the FDA?
Neoprobe Portable Radioisotope Detector (K864263) received a 510(k) decision of Substantially Equivalent on December 29, 1986, 61 days after the submission was received.
What is the product code of K864263?
The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.