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FDA 510(k)

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS

K-Number: K972903 · 1997-11-04

ApplicantImatron, Inc.
Decision Date1997-11-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS is the device name listed in this FDA 510(k) record. The listed applicant is Imatron, Inc.. It received FDA 510(k) clearance on 1997-11-04 under 510(k) number K972903. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS?

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Imatron, Inc.. The 510(k) number is K972903.

When did IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS receive FDA 510(k) clearance?

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS received FDA 510(k) clearance on 1997-11-04, under 510(k) number K972903.

Who is the listed applicant for IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS?

The FDA 510(k) record lists Imatron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS?

The FDA product code for IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS is JAK.

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Other records listing Imatron, Inc. 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.

K001550EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTRK000359EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTROK992740EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMSK972879ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTIONK913352C-150 ULTRAFAST CT SCANNERK874934UNIVERSAL EXAMINATION TABLE

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Related Devices (Code: JAK)

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Official Source

View on FDA Database →

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

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