Intelli-C— 510(k) K173631
Substantially EquivalentNrt X-Ray A/S
FDA 510(k) clearance K173631 for Intelli-C, Substantially Equivalent on 2018-07-11. Applicant: Nrt X-Ray A/S. Device class: 2.
Clearance details
- Applicant
- Nrt X-Ray A/S
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hasselager, DK
Recent devices under product code OWB
view allMore clearances from Nrt X-Ray A/S
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K173631
K-number listed on FDA's recall record- Z-1784-2024 — Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
- Z-1668-2023 — Intelli-C, Right side suspended Tabletop, REF: 03400000
- Z-1669-2023 — Intelli-C, Left side suspended Tabletop, REF: 03400010
- Z-0526-2022 — 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173631.
Data sourced from openFDA. This site is unofficial and independent of the FDA.