XILLIX-LIFE-LUNG
FDA premarket approval P950042/S001 · decided 1998-07-21
Approval details
- PMA number
- P950042
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- XILLIX-LIFE-LUNG
- Generic name
- SYSTEM, IMAGING, FLUORESCENCE
- Applicant
- Novadaq Technologies, Inc.
- Date received
- 1998-04-30
- Decision date
- 1998-07-21
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MRK
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Mississauga, Ontario
- Statement
- Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPY Phi Open Field Handheld Fluorescence Imaging System (K162885) | Novadaq Technologies, Inc. | 2017-01-11 |
| PINPOINT Endoscopic Fluorescence Imaging System (K161792) | Novadaq Technologies, Inc. | 2016-09-20 |
| PINPOINT Endoscopic Fluorescence Imaging System (K150956) | Novadaq Technologies, Inc. | 2016-05-23 |
| ENDOSCOPIC INTRODUCER (K123013) | Novadaq Technologies, Inc. | 2013-03-22 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM (K100371) | Novadaq Technologies, Inc. | 2011-02-04 |
| SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM (K091515) | Novadaq Technologies, Inc. | 2009-07-09 |
| SPY ANALYSIS TOOLKIT, MODEL SA9000 (K081792) | Novadaq Technologies, Inc. | 2008-09-17 |
| SPY FLUORESCENT IMAGING SYSTEM (K073130) | Novadaq Technologies, Inc. | 2008-01-10 |