K254021
Substantially EquivalentAccuro XV
Accuro XV is an ultrasound-based spine navigation device — Rivanna Medical's Accuro platform targets pre-procedure spinal landmarking for neuraxial anesthesia (epidurals, spinals) and lumbar punctures. Product code IYO covers ultrasound systems; the specific indication here is spine-landmark identification rather than general-purpose imaging.
Radiology panel, Traditional 510(k). Rivanna has filed repeatedly on this product code as the Accuro platform has evolved — the "XV" designation suggests a version update.
Rivanna Medical, Inc. files from Charlottesville, VA. Four-month review clock. Portable ultrasound with dedicated procedural indications is a distinct corner of IYO with a defined predicate lineage.
- Applicant
- Rivanna Medical, Inc.
- Product code
- IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.