Submission Details
| 510(k) Number | K182281 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 23, 2018 |
| Decision Date | October 24, 2018 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
Oct 2018
Decision
62d
Days
Class 2
Risk
About This 510(k) Submission
K182281 is an FDA 510(k) clearance for the Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by C. R. Bard (Salt Lake Ciy,, US). The FDA issued a Cleared decision on October 24, 2018, 62 days after receiving the submission on August 23, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.
Device Classification
| Product Code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
Manufacturer
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