VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
FDA 510(k) clearance K123898 · decided 2013-01-14
Clearance details
- K-number
- K123898
- Device name
- VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-12-18
- Decision date
- 2013-01-14
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rancho Cordova,, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Volcano Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Accuro 3S (K253452) | Rivanna Medical, Inc. | 2026-07-24 |
| ARTHUR (K260190) | ROPCA ApS | 2026-06-18 |
| EdgeFlow UW20 (K252237) | Edgecare, Inc. | 2026-04-17 |
| Accuro XV (K254021) | Rivanna Medical, Inc. | 2026-04-09 |
| QT Scanner 2000 Model A (K253898) | QT Imaging Holdings, Inc. | 2026-03-04 |
| IntraSight Plus (K253714) | Philips Image Guided Therapy Corporation | 2026-02-24 |
| Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (K253221) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| Astrasono A3Pro Bladder Scanner (A3Pro) (K250331) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| Deepsight NeedleVue LC1 Ultrasound System (K250381) | DeepSight Technology, Inc. | 2025-08-01 |
| B-Scan (K243227) | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| Velacur One (LI-1100) (K251728) | Sonic Incytes Medical Corp | 2025-06-26 |
| Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (K243880) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |