FDA 510(k) clearance · back to tracker

VERISTA IMAGING ISOCAM II GAMMA CAMERA

Verista Imaging, Inc. cleared K081757 on 2008-08-15, decision: substantially equivalent

K-number

K081757

Sponsor

Verista Imaging, Inc.

Device

VERISTA IMAGING ISOCAM II GAMMA CAMERA

Class

Class I

Decision

Substantially Equivalent

Decision date

2008-08-15

Product code

IYX

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1100

Official FDA record

Open K081757on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.