SPY IMAGING SYSTEM
FDA 510(k) clearance K063345 · decided 2007-01-12
Clearance details
- K-number
- K063345
- Device name
- SPY IMAGING SYSTEM
- Applicant
- Novadaq Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-06
- Decision date
- 2007-01-12
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mississauga, Ontario, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Novadaq Technologies
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 |
|---|---|---|
| 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037) | Stryker Endoscopy | 2026-05-28 |
| SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181) | Surgimage Corporation | 2026-05-13 |
| IC-Flow™ Imaging System 2.0 (K243645) | Diagnostic Green GmbH | 2025-09-22 |
| Affirm 800 (K243077) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 |
| Modus IR (K231986) | Synaptive Medical, Inc. | 2024-03-25 |
| EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090) | Surgvision GmbH | 2024-03-20 |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K230727) | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| EXPLORER AIR® II (K222240) | Surgvision GmbH | 2023-02-28 |
| Explorer Air II (K214097) | Surgvision GmbH | 2022-02-25 |
| DIR 800 (K202391) | Aesculap, Inc. | 2021-01-21 |
| Asimov-MKS Imaging System (K192761) | Onlume, Inc. | 2020-01-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S007) | Novadaq Technologies, Inc. | 2012-02-02 |
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S004) | Novadaq Technologies, Inc. | 2007-09-05 |
| ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE) (P950042/S003) | Novadaq Technologies, Inc. | 2005-06-30 |
| XILLIX-LIFE-LUNG (P950042/S001) | Novadaq Technologies, Inc. | 1998-07-21 |
| PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042) | Novadaq Technologies, Inc. | 1996-09-19 |