3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
Summary
Adaptiiv received 510(k) clearance for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory, a MUJ device. Cleared on 2022-01-19.
Details
Source
510(k) Clearance
External ID
K213438
Action Date
2022-01-19
Status
Traditional
Category
device
Product Code
MUJ
Product Description
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory. Product code: MUJ.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Adaptiiv have FDA actions?
This is the only FDA action we have on record for Adaptiiv in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213438" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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