INTELLISPACE PACS 4.X— 510(k) K111804
Substantially EquivalentPhilips Healthcare Informatics, Inc.
FDA 510(k) clearance K111804 for INTELLISPACE PACS 4.X, Substantially Equivalent on 2011-07-28. Applicant: Philips Healthcare Informatics, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Healthcare Informatics, Inc.
- 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
- Foster City, CA, US
Recent devices under product code LLZ
view allMore clearances from Philips Healthcare Informatics, Inc.
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 K111804
K-number listed on FDA's recall record- Z-2338-2020 — IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
- Z-2252-2014 — Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111804.
Data sourced from openFDA. This site is unofficial and independent of the FDA.