MAIA, MODEL 1
FDA 510(k) clearance K092187 · decided 2010-05-27
Clearance details
- K-number
- K092187
- Device name
- MAIA, MODEL 1
- Applicant
- Centervue S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-21
- Decision date
- 2010-05-27
- Days to decision
- 310 days
- Clearance type
- Traditional
- Product code
- HPT
- Device class
- 1
- Regulation number
- 886.1605
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Padova, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (K093213) | Carl Zeiss Meditec, Inc. | 2010-03-12 |
| FORESEE HOME (K091579) | Notal Vision , Ltd. | 2009-12-23 |
| TRUEFIELD ANALYZER (K063310) | Seeing Machines Limited | 2007-08-02 |
| THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) (K050350) | Notal Vision, Inc. | 2005-04-29 |
| NOVAVISION, MODEL 2.0 (K023623) | Novavision, Inc. | 2003-04-22 |
| KASHA VISUAL FIELD SYSTEM (K971156) | Kasha Software, Inc. | 1997-05-28 |
| AUTOMATIC VISUAL FIELD PLOTTER AP-125 (K961090) | Kowa Optimed, Inc. | 1996-06-17 |
| HUMPHREY FIELD ANALYZER (HFA II) (K954167) | Carl Zeiss, Inc. | 1995-11-24 |
| FIELD TREND (K954037) | Synemed, Inc. | 1995-11-17 |
| MS-30 AUTOMATIC PERIMETER (K943234) | Marco Ophthalmic, Inc. | 1994-07-27 |
| OPTICOM M600 (K932258) | Clement Clarke, Inc. | 1994-07-25 |
| LD 400 (K930937) | Vismed, Inc. | 1993-10-18 |
Recalls involving this device
No recalls on record reference this clearance.