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510(k) K202391

Device
DIR 800
Applicant
Aesculap, Inc.
510(k) number
K202391
Product code
IZI  
Decision
Substantially Equivalent (SESE)
Decision date
2021-01-21
Date received
2020-08-21
Regulation
892.1600
Classification name
System, X-ray, Angiographic
Medical specialty
Radiology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kathy A. Racosky
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IZI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy2026-05-28
K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation2026-05-13
K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH2025-09-22
K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)2025-06-27
K231986Modus IRSynaptive Medical, Inc.2024-03-25
K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH2024-03-20
K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.2023-06-20
K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)2023-06-05
K222240EXPLORER AIR® IISurgvision GmbH2023-02-28
K214097Explorer Air IISurgvision GmbH2022-02-25
K192761Asimov-MKS Imaging SystemOnlume, Inc.2020-01-17
K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.2019-10-10
K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2019-01-23
K181537GLOW800Leica Microsystems (Schweiz) AG2018-09-07
K180019CAAS WorkstationPie Medical Imaging BV2018-05-03

Legacy Summary#

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FDA Review#

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