Imager, Body Section, Radionuclide
FDA 510(k) K780395 · Union Carbide Corp.
510(k) numberK780395
Submission
- Device name
- Imager, Body Section, Radionuclide
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- March 13, 1978
- Decision date
- March 31, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944684 | Polyscan Digital ScannerIYW · Traditional | Mse Medizintechnik GmbH & Co. KG | 05/15/1995SE |
| K895799 | Rectilinear Scanner Model #187-270IYW · Traditional | Atomic Products Corp. | 02/01/1990SE |
| K882453 | Polyscan Digital ScannerIYW · Traditional | Medical and Scientific Enterprises, Inc. | 11/23/1988SE |
More from Medical and Scientific Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830337 | Mark III Oxygen Walker Sys-Low PressBYJ · Traditional | 03/17/1983SE |
| K820836 | Mark III Oxygen Walker SystemBYJ · Traditional | 04/15/1982SE |
| K820535 | Laser Gas MixturesEWG · Traditional | 03/31/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
Questions and answers
When was Imager, Body Section, Radionuclide cleared by the FDA?
Imager, Body Section, Radionuclide (K780395) received a 510(k) decision of Substantially Equivalent on March 31, 1978, 18 days after the submission was received.
What is the product code of K780395?
The FDA product code is IYW – Scanner, Rectilinear, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1300.