PANORAMIC 200A
FDA 510(k) clearance K042001 · decided 2004-10-07
Clearance details
- K-number
- K042001
- Device name
- PANORAMIC 200A
- Applicant
- Optos Plc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-26
- Decision date
- 2004-10-07
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- HLI
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Optos Plc.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RTVue XR OCT Avanti with AngioVue Software (K153080) | Optovue, Inc. | 2016-02-11 |
| EnFocus 2300, EnFocus 4400 (K150722) | Bioptigen, Inc. | 2015-12-02 |
| OCT-Camera (K142953) | Optomedical Technologies GmbH | 2015-03-04 |
| PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (K141638) | Propper Manufacturing Co., Inc. | 2014-09-17 |
| CENTERVUE MACULAR INTEGRITY ASSESSMENT (K133758) | Centervue S.P.A. | 2014-04-23 |
| AMICO DH-W35 OPHTHALMOSCOPE SERIES (K131939) | Amico Diagnostic Incorporated | 2014-03-26 |
| IVUE 500 (K133892) | Optovue, Inc. | 2014-03-19 |
| HEINE OMEGA 500 (K123316) | Heine Optotechnik GmbH & Co. KG | 2013-02-26 |
| IVUE WITH NORMATIVE DATABASE (K121739) | Optovue, Inc. | 2013-01-18 |
| ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (K120057) | Bioptigen, Inc. | 2012-05-11 |
| RTVUE XR OCT (K120238) | Optovue, Inc. | 2012-04-03 |
| RHA2020 (K111531) | Annidis Health Systems Corp. | 2011-07-08 |
Recalls involving this device
No recalls on record reference this clearance.