Ilab Ultrasound Imaging System
FDA 510(k) K123535 · Boston Scientific Corp
510(k) numberK123535
Submission
- Device name
- Ilab Ultrasound Imaging System
- Applicant
- Boston Scientific Corp
Fremont, CA, US - Received
- November 16, 2012
- Decision date
- January 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
| K262460 | Rezum SystemKNS · Traditional | 09/03/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was Ilab Ultrasound Imaging System cleared by the FDA?
Ilab Ultrasound Imaging System (K123535) received a 510(k) decision of Substantially Equivalent on January 15, 2013, 60 days after the submission was received.
What is the product code of K123535?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.