MSK EXTREME MR SCANNER, MODEL AA5000— 510(k) K080048
Substantially EquivalentOni Medical Systems, Inc.
FDA 510(k) clearance K080048 for MSK EXTREME MR SCANNER, MODEL AA5000, Substantially Equivalent on 2008-02-06. Applicant: Oni Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Oni Medical Systems, Inc.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wilmington, MA, US
Recent devices under product code LNH
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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 K080048
K-number listed on FDA's recall record- Z-1927-2016 — MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
- Z-1211-2013 — MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080048.
Data sourced from openFDA. This site is unofficial and independent of the FDA.