CIRCLEXO.3T X-RAY TUBE ASSEMBLY— 510(k) K920387
Substantially EquivalentShimadzu Medical Systems
FDA 510(k) clearance K920387 for CIRCLEXO.3T X-RAY TUBE ASSEMBLY, Substantially Equivalent on 1992-04-14. Applicant: Shimadzu Medical Systems. Device class: 1.
Clearance details
- Applicant
- Shimadzu Medical Systems
- Product code
- Code ITY
- Device class
- Class 1
- Regulation
- 21 CFR 892.1760
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gardena, CA, US
Recent devices under product code ITY
view allMore clearances from Shimadzu Medical Systems
view all- K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
- K071287 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
- 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
Adverse events under product code ITY
product code ITY- Other
- 1
- Total
- 1
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.