BELLYBOARD, SBRT ACCESSORIES— 510(k) K121545
Substantially EquivalentMedtec Inc. Dba Civco Medical Solutions
FDA 510(k) clearance K121545 for BELLYBOARD, SBRT ACCESSORIES, Substantially Equivalent on 2012-06-08. Applicant: Medtec Inc. Dba Civco Medical Solutions. Device class: 2.
Clearance details
- Applicant
- Medtec Inc. Dba Civco Medical Solutions
- 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
- Orange City, IA, US
Recent devices under product code LNH
view allMore clearances from Medtec Inc. Dba Civco Medical Solutions
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 K121545
K-number listed on FDA's recall record- Z-0802-2014 — Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
- Z-0803-2014 — Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121545.
Data sourced from openFDA. This site is unofficial and independent of the FDA.