DR5000 DEDICATED CHEST X-RAY SYSTEM— 510(k) K001341
Substantially EquivalentAnalogic Corp.
FDA 510(k) clearance K001341 for DR5000 DEDICATED CHEST X-RAY SYSTEM, Substantially Equivalent on 2000-06-02. Applicant: Analogic Corp.. Device class: 2.
Clearance details
- Applicant
- Analogic Corp.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Peabody, MA, US
Recent devices under product code KPR
view allMore clearances from Analogic Corp.
view all- K071430 — SYNERAD OMNI, MODELS AN6255 AND AN6265
- K052447 — SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
- K050919 — LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
- K043025 — SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
- K041434 — C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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.