SPY Portable Handheld Imaging (SPY-PHI) System
FDA 510(k) K190729 · Novadaq Technologies Ulc. (Now A Part of Stryker)
510(k) numberK190729
Submission
- Device name
- SPY Portable Handheld Imaging (SPY-PHI) System
- Applicant
- Novadaq Technologies Ulc. (Now A Part of Stryker)
Burnaby, CA - Received
- March 21, 2019
- Decision date
- April 19, 2019
- Decision
- Unknown (SESD)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
Other 510(k)s with product code OWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254180 | PerfusiX-ImagingOWN · Traditional | LIMIS Development B.V. | 07/24/2026SE |
| K242163 | SmartSurgN Visualization SystemOWN · Traditional | SmartsurgN, Inc. | 04/20/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | Karl Storz SE & CO. KG | 02/26/2026SE |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)OWN · Traditional | VPIX Medical, Inc. | 02/13/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | Stryker Endoscopy | 02/12/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | Karl Storz SE & CO. KG | 02/12/2026SE |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…OWN · Traditional | Olympus Medical Systems Corp. | 11/12/2025SE |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…OWN · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 07/24/2025SE |
| K243591 | OPTOVISION Endoscopic Light Source UnitOWN · Traditional | Optosurgical, LLC | 02/19/2025SE |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3)OWN · Traditional | Samantree Medical SA | 08/19/2024SE |
More from Samantree Medical SA
| 510(k) | Device | Decision |
|---|---|---|
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareOWN · Traditional | 11/05/2020SE |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | 05/21/2020SE |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | 11/15/2019SE |
| K182907 | SPY Elite Intraoperative Perfusion Assessment SystemIZI · Traditional | 01/23/2019SE |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging SystemGCJ · Traditional | 11/21/2018SE |
Questions and answers
When was SPY Portable Handheld Imaging (SPY-PHI) System cleared by the FDA?
SPY Portable Handheld Imaging (SPY-PHI) System (K190729) received a 510(k) decision of Unknown on April 19, 2019, 29 days after the submission was received.
What is the product code of K190729?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.