510(k) K202244
- Device
- SPY-PHI System With SPY-PHI Fluorescence Assessment Software
- Applicant
- Novadaq Technologies ULC (now A Part Of Stryker)
- 510(k) number
- K202244
- Product code
- OWN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-11-05
- Date received
- 2020-08-10
- Regulation
- 876.1500
- Classification name
- Confocal Optical Imaging
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Agatha Szeliga
- Address
- 8329 Eastlake Dr. Unit 101 Burnaby CA V5A 4W2 V5A 4W2
FDA Registration Numbers#
- 3021336392
- 1220246
- 2027009
- 3024021261
- 3015612252
- 3013247477
- 3012345110
- 3010590422
- 3012322232
- 3016493665
- 3015231789
- 9614434
- 9612074
- 3021744379
- 3007303113
- 9610773
- 3026753388
- 3010177712
- 3009057691
- 3014321789
- 3015532525
- 3041276556
- 3015515531
- 3029968414
- 9614683
- 3010707607
- 8010047
- 9610617
- 3010202439
- 2936485
- 3018094310
- 3011092264
- 2031093
- 3002808148
- 2020550
- 3010331645
- 3014342096
- 3008837339
- 3014644276
- 8043903
- 3006990600
- 9615010
- 3026934906
- 3001675293
- 3006973663
- 3011459664
- 3004542960
Source Documents#
Other 510(k) Records For Product Code OWN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242163 | SmartSurgN Visualization System | SmartsurgN, Inc. | 2026-04-20 |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026-02-26 |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. | 2026-02-13 |
| K260108 | L12 LED Light Source with AIM | Stryker Endoscopy | 2026-02-12 |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | 2026-02-12 |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Olympus Medical Systems Corp. | 2025-11-12 |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-07-24 |
| K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | 2025-02-19 |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA | 2024-08-19 |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | 2023-11-21 |
| K232857 | KARL STORZ ICG Imaging System | Karl Storz SE & CO. KG | 2023-11-06 |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | Stryker | 2023-09-20 |
| K231344 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | 2023-08-02 |
| K230407 | FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | 2023-07-17 |
| K230754 | L12 LED Light Source with AIM | Stryker | 2023-04-11 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases