LIXI IMAGING SCOPE. MODIFICATION
FDA 510(k) clearance K925251 · decided 1992-12-28
Clearance details
- K-number
- K925251
- Device name
- LIXI IMAGING SCOPE. MODIFICATION
- Applicant
- Lixi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-16
- Decision date
- 1992-12-28
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Downers Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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| Nautilus (K220871) | Dornier Medtech America, Inc. | 2022-04-18 |
| Nyquist.IQ (K212890) | Omega Medical Imaging, LLC | 2021-12-13 |
| ProxiDiagnost N90 (K212837) | Philips Medical Systems Dmc GmbH | 2021-09-21 |
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Recalls involving this device
No recalls on record reference this clearance.