BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
Summary
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla received 510(k) clearance for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002), a IYE device. Cleared on 2024-05-31.
Details
Source
510(k) Clearance
External ID
K232738
Action Date
2024-05-31
Status
Traditional
Category
device
Product Code
IYE
Product Description
BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002). Product code: IYE.
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. Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla has received 2 total clearances in our database.
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla has 2 FDA actions in our database, including 2 clearances.
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 Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla have FDA actions?
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232738" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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