POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W— 510(k) K894056
Substantially EquivalentShimadzu Medical Systems
FDA 510(k) clearance K894056 for POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W, Substantially Equivalent on 1989-11-15. Applicant: Shimadzu Medical Systems. Device class: 2.
Clearance details
- Applicant
- Shimadzu Medical Systems
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gardena, CA, US
Recent devices under product code KPS
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- K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
- K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
- K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
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