510(k) clearances

ART-Plan+ (v.3.0.0)

Therapanacea Sas · Radiology

K242822Substantially EquivalentTraditionalMUJ
Open FDA's page for this record
Third party flag
N
City
Paris
Advisory committee description
Radiology
Address 1
7 Bis Blvd. Bourdon
Statement or summary
Summary
Product code
MUJ
Zip code
75004
Applicant
Therapanacea Sas
Decision date
2025-02-25
Decision code
SESE
Country code
FR
Device name
ART-Plan+ (v.3.0.0)
Advisory committee
RA
Contact
Bhairavi Ajachandra
K number
K242822
Date received
2024-09-18
Review advisory committee
RA
Postal code
75004
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Planning, Radiation Therapy Treatment
Medical specialty description
Radiology
Regulation number
892.5050
Device class
2
Registration number
3015777306, 3010123525, 3009090417, 3019834893, 3019543601, 3014425747, 3004580128, 3003586672, 2434141, 1038814, 3022719374, 9617978, 3003873069, 3009302839, 3030564015, 3007791541, 3014873236, 3003768277, 1651102, 3003418325, 2939248, 3006579682, 2916710, 3000126629, 3004561814, 3016602874, 3025765259, 3033527281, 3002808157, 3016686005, 9611894, 3023344262, 8043933, 3022745617, 3007037519, 3013410552, 3004363352, 3003793371, 2030598, 3012039133 +16 more
FEI number
3015777306, 3010123525, 3009090417, 3019834893, 3019543601, 3002807880, 3014425747, 3003586672, 3004580128, 3002802883, 2434141, 3022719374, 1038814, 3003873069, 3009302839, 3030564015, 3007791541, 3014873236, 3008581796, 3003418325, 2939248, 3006579682, 2916710, 3000126629, 3004561814, 3016602874, 3025765259, 3002807741, 3033527281, 3002808157, 3016686005, 3023344262, 3022745617, 3007037519, 3013410552, 3004363352, 3003793371, 3012039133, 3015232217, 1000518731 +16 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.