ORTHOSCAN, ORTHOSCAN HD— 510(k) K051754
Substantially EquivalentOrthoscan, Inc.
FDA 510(k) clearance K051754 for ORTHOSCAN, ORTHOSCAN HD, Substantially Equivalent on 2005-08-09. Applicant: Orthoscan, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthoscan, Inc.
- Product code
- Code OXO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Recent devices under product code OXO
view allMore clearances from Orthoscan, Inc.
view allAdverse events under product code OXO
product code OXO- Death
- 6
- Injury
- 163
- Malfunction
- 2,099
- Other
- 1
- Total
- 2,269
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 →
Recalls naming K051754
K-number listed on FDA's recall record- Z-0258-2018 — Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
- Z-0259-2018 — Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051754.
Data sourced from openFDA. This site is unofficial and independent of the FDA.