WISE IMAGE MANAGEMENT SYSTEM— 510(k) K971451
Substantially EquivalentO Tech, Inc.
FDA 510(k) clearance K971451 for WISE IMAGE MANAGEMENT SYSTEM, Substantially Equivalent on 1997-06-26. Applicant: O Tech, Inc.. Device class: 1.
Clearance details
- Applicant
- O Tech, Inc.
- Product code
- Code LMB
- Device class
- Class 1
- Regulation
- 21 CFR 892.2010
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
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