MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM— 510(k) K000630
Substantially EquivalentHopkins Imaging Systems, Inc.
FDA 510(k) clearance K000630 for MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM, Substantially Equivalent on 2000-05-12. Applicant: Hopkins Imaging Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Hopkins Imaging Systems, 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
- Duarte, CA, US
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.