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Santa Barbara Imaging Systems, Inc.

USA · Goleta

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

12listed device types

Class I 8Class II 4Class III 0

plus 22 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

16 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

19active ARTG entries

Class I 16IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States22 registration records, 10 510(k), 0 PMA, 1 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: SANTA BARBARA IMAGING SYSTEMS · Santa Barbara Imaging Systems, Inc.

FDA 510(k) clearances by year

11980

31981

11982

11983

11984

11985

12015

12023

FDA listed device types

showing 8 of 12

Light, Surgical, Fiberoptic 1Arthroscope 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Laparoscope, General & Plastic Surgery 1Accessory Equipment, Cardiopulmonary Bypass 1System, Digital Image Communications, Radiological 1Camera, Television, Surgical, With Audio 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223116	8X-10-6XXX Camera Head	2023-02-28
US	K152513	8X-10-XXXX Camera System	2015-12-15
US	K850492	NASAL SEPTAL BUTTON	1985-03-07
SA	ME0000006868SFDAA00001	ZEOS 4K UHD Camera Head C-Mount, COMS	—
SA	ME0000006869SFDAA00001	ZEOS Zoom Coupler, F=16-34MM	—
CA	100034	TRINITY CAMERA SYSTEM	Class II
CA	101783	PIXA CAMERA SYSTEM	Class II
CA	101888	ZEOS CAMERA SYSTEM	Class II

Santa Barbara Imaging Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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