NovaGuide 2 Intelligent Ultrasound
FDA 510(k) clearance K213279 · decided 2022-03-02
Clearance details
- K-number
- K213279
- Device name
- NovaGuide 2 Intelligent Ultrasound
- Applicant
- Novasignal Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-10-01
- Decision date
- 2022-03-02
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA recall (Z-2216-2024) | NovaSignal Corp. | 2024-06-27 |
| NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 recall (Z-2217-2024) | NovaSignal Corp. | 2024-06-27 |