Probe, Uptake, Nuclear
FDA 510(k) K864624 · Carolina Medical Electronics
510(k) numberK864624
Submission
- Device name
- Probe, Uptake, Nuclear
- Applicant
- Carolina Medical Electronics
King, NC, US - Received
- November 25, 1986
- Decision date
- August 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
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| K874684 | TC2-64B Transcranial DopplerIYO · Traditional | 04/25/1988SE |
| K843891 | Dopscan Plus DS1060IYO · Traditional | 01/09/1985SE |
| K837329 | Sonacolor CD, Model 6300 Cardiac Doppler Ultrasound · Traditional | 06/07/1983SE |
| K820272 | Cliniflow II, #701, Electromagn. Bld. SyDPW · Traditional | 03/12/1982SE |
| K810561 | Dopscan Model 1050DPW · Traditional | 04/10/1981SE |
| K801647 | Sonacolor 6100DXY · Traditional | 08/20/1980SE |
| K792540 | Sonacolor 6000DXK · Traditional | 01/17/1980SE |
| K772015 | Patient Heater System, Model PH112DWJ · Traditional | 11/15/1977SE |
Questions and answers
When was Probe, Uptake, Nuclear cleared by the FDA?
Probe, Uptake, Nuclear (K864624) received a 510(k) decision of Substantially Equivalent on August 10, 1987, 258 days after the submission was received.
What is the product code of K864624?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.