Rectilinear Scanner Model #187-270
FDA 510(k) K895799 · Atomic Products Corp.
510(k) numberK895799
Submission
- Device name
- Rectilinear Scanner Model #187-270
- Applicant
- Atomic Products Corp.
Shirley, NY, US - Received
- September 28, 1989
- Decision date
- February 1, 1990
- 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 |
| K882453 | Polyscan Digital ScannerIYW · Traditional | Medical and Scientific Enterprises, Inc. | 11/23/1988SE |
| K780395 | Imager, Body Section, RadionuclideIYW · Traditional | Union Carbide Corp. | 03/31/1978SE |
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| K915541 | SPECT Table, Model #056-760IYZ · Traditional | 01/17/1992SE |
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| K904187 | Economy C-Arm Table, Model # 056-005IXQ · Traditional | 11/29/1990SE |
| K904623 | Radiographic Transport, Trauma Model 056-230, 235IXQ · Traditional | 11/06/1990SE |
| K900851 | Digital Image Enhancement SystemLLZ · Traditional | 05/11/1990SE |
| K884312 | Atomlab 100, Model 086-250 & 200 Model 086-270KPT · Traditional | 02/16/1989SE |
| K871868 | Venti-Scan IIIYT · Traditional | 04/11/1988SE |
| K874332 | MRI StretcherFPO · Traditional | 01/05/1988SE |
| K790835 | DynajectDXT · Traditional | 06/22/1979SE |
Questions and answers
When was Rectilinear Scanner Model #187-270 cleared by the FDA?
Rectilinear Scanner Model #187-270 (K895799) received a 510(k) decision of Substantially Equivalent on February 1, 1990, 126 days after the submission was received.
What is the product code of K895799?
The FDA product code is IYW – Scanner, Rectilinear, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1300.