510(k) K231075
- Device
- Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- Applicant
- Carl Zeiss Meditec, Inc.
- 510(k) number
- K231075
- Product code
- IZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-20
- Date received
- 2023-04-14
- Regulation
- 892.1600
- Classification name
- System, X-Ray, Angiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chaitali Gawde
- Address
- 5300 Central Pkwy. Dublin CA US 94568 94568
FDA Registration Numbers#
- 3007138831
- 3013700547
- 1061124
- 1000181430
- 3010331645
- 3015806723
- 3015532525
- 3008403546
- 3035950510
- 3027373189
- 3012075008
- 3010326005
- 9615010
- 3015974593
- 3023003446
- 2936485
- 1220246
- 3021336182
- 8010047
- 3020899789
- 2648727
- 3012624817
- 1036836
- 3014262693
- 3038614464
- 3016851379
- 8020997
- 3008284470
- 3015276088
- 1000204638
- 3004122598
- 9613445
- 3008496839
- 3011230048
- 1054713
- 3015231789
- 2521402
- 3012127758
- 3030926959
- 3042243691
- 8043903
- 3014004349
- 3010193531
- 3036666444
- 9614683
- 3015180671
- 3009077524
- 3031503890
- 3009057691
- 3014644276
- 9611343
- 3031594238
- 3005810333
- 1055236
- 2916714
- 3003637092
- 3026391023
- 3021059265
- 3018126215
- 3002579136
- 3003202425
- 3019269298
- 3020704423
- 1625425
- 3006972752
- 3010400367
- 3003755939
- 3012470322
- 2523676
- 3007289408
- 3015173212
- 3027339877
- 3022626486
- 1048735
- 3021226419
- 3007055152
- 3012329552
- 3042175844
- 3013283620
Source Documents#
Other 510(k) Records For Product Code IZI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | 2026-05-28 |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | Surgimage Corporation | 2026-05-13 |
| K243645 | IC-Flow™ Imaging System 2.0 | Diagnostic Green GmbH | 2025-09-22 |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 |
| K231986 | Modus IR | Synaptive Medical, Inc. | 2024-03-25 |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | 2024-03-20 |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| K222240 | EXPLORER AIR® II | Surgvision GmbH | 2023-02-28 |
| K214097 | Explorer Air II | Surgvision GmbH | 2022-02-25 |
| K202391 | DIR 800 | Aesculap, Inc. | 2021-01-21 |
| K192761 | Asimov-MKS Imaging System | Onlume, Inc. | 2020-01-17 |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | 2019-10-10 |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-01-23 |
| K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | 2018-09-07 |
| K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018-05-03 |