SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM— 510(k) K932244
Substantially EquivalentShimadzu Medical Systems
FDA 510(k) clearance K932244 for SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM, Substantially Equivalent on 1994-02-18. Applicant: Shimadzu Medical Systems. Device class: 2.
Clearance details
- Applicant
- Shimadzu Medical Systems
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gardena, CA, US
Recent devices under product code LNH
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 LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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.