Wireless Digital Flat Panel Detector— 510(k) K182550
Substantially EquivalentIray Technology Taicang , Ltd.
FDA 510(k) clearance K182550 for Wireless Digital Flat Panel Detector, Substantially Equivalent on 2018-10-17. Applicant: Iray Technology Taicang , Ltd.. Device class: 2.
Clearance details
- Applicant
- Iray Technology Taicang , Ltd.
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taicang, CN
Recent devices under product code MQB
view allMore clearances from Iray Technology Taicang , Ltd.
view allRecalls naming K182550
K-number listed on FDA's recall record- Z-2213-2020 — Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.
- Z-2215-2020 — Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182550.
Data sourced from openFDA. This site is unofficial and independent of the FDA.