DYNACAD V1.0— 510(k) K041286
Substantially EquivalentMri Devices Corp.
FDA 510(k) clearance K041286 for DYNACAD V1.0, Substantially Equivalent on 2004-07-21. Applicant: Mri Devices Corp.. Device class: 2.
Clearance details
- Applicant
- Mri Devices Corp.
- 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
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code LNH
view allMore clearances from Mri Devices Corp.
view all- K041481 — MODEL BBC-127 BIOPSY BREAST COIL
- K040348 — MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
- K040349 — MODIFICATION TO HRW-127 WRIST ARRAY COIL
- K040288 — QSC-127-INT SHOULDER ARRAY COIL SET
- K033447 — CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.