S.K. Diag. Ultrasnd. Small Parts Scan
FDA 510(k) K800531 · Smithkline Diagnostics, Inc.
510(k) numberK800531
Submission
- Device name
- S.K. Diag. Ultrasnd. Small Parts Scan
- Applicant
- Smithkline Diagnostics, Inc.
Mchenry, IL, US - Received
- March 7, 1980
- Decision date
- April 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253452 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K260190 | ArthurIYO · Traditional | ROPCA ApS | 06/18/2026SE |
| K252237 | EdgeFlow UW20IYO · Traditional | Edgecare, Inc. | 04/17/2026SE |
| K254021 | Accuro XVIYO · Traditional | Rivanna Medical, Inc. | 04/09/2026SE |
| K253898 | QT Scanner 2000 Model AIYO · Special | QT Imaging Holdings, Inc. | 03/04/2026SE |
| K253714 | IntraSight PlusIYO · Traditional | Philips Image Guided Therapy Corporation | 02/24/2026SE |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)IYO · Traditional | Eieling Technology (Shenzhen) Limited | 02/06/2026SE |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional | Astrasono Technology Co., Ltd. | 09/30/2025SE |
| K250381 | Deepsight NeedleVue LC1 Ultrasound SystemIYO · Traditional | DeepSight Technology, Inc. | 08/01/2025SE |
| K243227 | B-ScanIYO · Traditional | Accutome, Inc. Doing Business AS Keeler USA | 07/11/2025SE |
More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K961062 | Flexsure ObtKHE · Traditional | 11/06/1996SE |
| K960183 | Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for…LYR · Traditional | 06/07/1996SE |
| K934863 | Flexsure HPLYR · Traditional | 05/18/1994SE |
| K880499 | Hemoccult Sensitive TestKHE · Traditional | 05/23/1988SE |
| K875131 | (SKD) Cholesterol Test KitCHH · Traditional | 03/01/1988SE |
| K862849 | Hemoccult Wipe TestKHE · Traditional | 12/09/1986SE |
| K854723 | SKD Electrochemical System (Ecs)CEM · Traditional | 03/05/1986SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | 07/24/1985SE |
| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
| K821674 | Spinchem Acid Phosphatase ReagentCKB · Traditional | 06/22/1982SE |
Questions and answers
When was S.K. Diag. Ultrasnd. Small Parts Scan cleared by the FDA?
S.K. Diag. Ultrasnd. Small Parts Scan (K800531) received a 510(k) decision of Substantially Equivalent on April 10, 1980, 34 days after the submission was received.
What is the product code of K800531?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.