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FDA 510(k)

SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)

K-Number: K931170 · 1993-06-14

ApplicantSony Medical Systems
Decision Date1993-06-14
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) is the device name listed in this FDA 510(k) record. The listed applicant is Sony Medical Systems. It received FDA 510(k) clearance on 1993-06-14 under 510(k) number K931170. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)?

SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) is a medical device that received FDA 510(k) clearance on 1993-06-14. The listed applicant is Sony Medical Systems. The 510(k) number is K931170.

When did SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) receive FDA 510(k) clearance?

SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) received FDA 510(k) clearance on 1993-06-14, under 510(k) number K931170.

Who is the listed applicant for SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)?

The FDA 510(k) record lists Sony Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)?

The FDA product code for SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) is IZI.

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Other records listing Sony Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K024188UP-DF500 FILMSTATION DIGITAL FILM IMAGERK970999SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITORK961680SONY DKR-700 DIGITAL STILL RECORDERK924708CINENET CARDIAC IMAGE NETWORKK921275SONY LASER VIDEODISC RECORDING SYSTEM

Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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