SCANIP; SCANIP: MEDICAL EDITION— 510(k) K142779
Substantially EquivalentSimpleware , Ltd.
FDA 510(k) clearance K142779 for SCANIP; SCANIP: MEDICAL EDITION, Substantially Equivalent on 2015-04-17. Applicant: Simpleware , Ltd.. Device class: 2.
Clearance details
- Device name as filed
- SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED
- Applicant
- Simpleware , Ltd.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Exeter, GB
Recent devices under product code LLZ
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 K142779
K-number listed on FDA's recall record- Z-2253-2021 — Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
- Z-2254-2021 — Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142779.
Data sourced from openFDA. This site is unofficial and independent of the FDA.