SPY Portable Handheld Imaging (SPY-PHI) System— 510(k) K190729
UnknownNovadaq Technologies Ulc. (Now A Part of Stryker)
FDA 510(k) clearance K190729 for SPY Portable Handheld Imaging (SPY-PHI) System, Unknown on 2019-04-19. Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker). Device class: 2.
Clearance details
- Applicant
- Novadaq Technologies Ulc. (Now A Part of Stryker)
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Burnaby, CA
Recent devices under product code OWN
view allMore clearances from Novadaq Technologies Ulc. (Now A Part of Stryker)
view all- K202244 — SPY-PHI System with SPY-PHI Fluorescence Assessment Software
- K200737 — SPY Portable Handheld Imaging (SPY-PHI) System
- K192174 — SPY Portable Handheld Imaging (SPY-PHI) System
- K182907 — SPY Elite Intraoperative Perfusion Assessment System
- K182606 — PINPOINT Endoscopic Fluorescence Imaging System
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.