510(k) clearances

Quicktome Software Suite

Omniscient Neurotechnology Pty, Ltd. · Radiology

K261795Substantially EquivalentTraditionalQIH
Open FDA's page for this record
Third party flag
N
City
Haymarket
Advisory committee description
Radiology
Address 1
Suite L1.108, 477 Pitt St.
Statement or summary
Summary
Product code
QIH
Zip code
2000
Applicant
Omniscient Neurotechnology Pty, Ltd.
Decision date
2026-09-10
Decision code
SESE
Country code
AU
Device name
Quicktome Software Suite
Advisory committee
RA
Contact
Arie Henkin
K number
K261795
Date received
2026-05-29
Review advisory committee
RA
Postal code
2000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Automated Radiological Image Processing Software
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
8043836, 3019844085, 3016461002, 8022257, 3013410552, 3019541896, 3033527283, 3008693672, 3013552417, 3017210169, 3003594449, 1000432246, 9710090, 3020928588, 9616047, 3040335643, 3015516266, 9617277, 3030655434, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3007630531, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 9616251, 2936485 +197 more
FEI number
3019844085, 3016461002, 3013410552, 3019541896, 3002807692, 3003309342, 3033527283, 3008693672, 3002087856, 3010289997, 3013552417, 3003594449, 3017210169, 1000432246, 3002807880, 3020928588, 3040335643, 3015516266, 3030655434, 3007630531, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3003190524, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 2936485 +197 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.