510(k) K984545
- Device
- RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
- Applicant
- PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
- 510(k) number
- K984545
- Product code
- IZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-25
- Date received
- 1998-12-22
- 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
- P. ALTMAN
- Address
- Veenpluis 4-6 P.O. Box 10000 Da Best NL 5680 5680
FDA Registration Numbers#
- 3029968414
- 3015153469
- 3004519921
- 3014262693
- 3009077524
- 3017820152
- 3000976525
- 3010400367
- 3021226419
- 3020899789
- 3026606306
- 3027339877
- 3007138831
- 9610612
- 3000126629
- 3020746799
- 3013764800
- 3015173212
- 3015532525
- 3008309062
- 1055236
- 3009715136
- 3015895145
- 9710122
- 3014321789
- 8043903
- 3014343100
- 3035950510
- 3016851379
- 3009057691
- 3013077751
- 9615010
- 3015232217
- 3002579136
- 3006498370
- 1037885
- 3008284470
- 3010493171
- 3014644276
- 3019269298
- 3011230048
- 3006972752
- 3014635169
- 3015910259
- 3038614464
- 3033527282
- 3014004349
- 3026391023
- 1061124
- 3003974370
- 3016607092
- 3014663814
- 3004111573
- 3007289408
- 3045816907
- 3015276088
- 1018470
- 9611343
- 3003202425
- 1000204638
- 2523676
- 3011063460
- 3042940623
- 1054241
- 1054713
- 3013767421
- 3020331900
- 3015180671
- 3012939903
- 3021393544
- 2648727
- 3009719225
- 3031503890
- 3036666444
- 3008632256
- 3012470322
- 3010885402
- 3021336182
- 1000181430
- 3012624817
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 |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| 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 |
Legacy Summary#
summary
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