SPECT Table, Model #056-760
FDA 510(k) K915541 · Atomic Products Corp.
510(k) numberK915541
Submission
- Device name
- SPECT Table, Model #056-760
- Applicant
- Atomic Products Corp.
Shirley, NY, US - Received
- December 10, 1991
- Decision date
- January 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K912181 | E-Z Lift Crank Imaging TableIYZ · Traditional | Med-Tron Products, Inc. | 07/17/1991SE |
| K912135 | Xy Imaging TableIYZ · Traditional | Med-Tron Products, Inc. | 07/17/1991SE |
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| K903767 | Ect (Emmission Computed Tomography) Carbon Fib PalIYZ · Traditional | Siemens Gammasonics, Inc. | 09/07/1990SE |
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| K900851 | Digital Image Enhancement SystemLLZ · Traditional | 05/11/1990SE |
| K895799 | Rectilinear Scanner Model #187-270IYW · Traditional | 02/01/1990SE |
| 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 SPECT Table, Model #056-760 cleared by the FDA?
SPECT Table, Model #056-760 (K915541) received a 510(k) decision of Substantially Equivalent on January 17, 1992, 38 days after the submission was received.
What is the product code of K915541?
The FDA product code is IYZ – Bed, Scanning, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1350.