Product Code: MWW FDA class 2 21 CFR 892.5050

Accessory - Film Dosimetry System

Radiology

A Film Dosimetry System Accessory is a component or supplementary element used with radiation film dosimetry systems to measure and record absorbed radiation doses for quality assurance and calibration in radiation therapy or diagnostic radiology settings. It is FDA Class 2, requiring 510(k) clearance, with product code MWW under 21 CFR 892.5050 in the Radiology specialty. The device is not an implant and is not life-sustaining.

510(k)s
0
FEI Numbers
4
Registration Numbers
4
Unique Applicants
0
Years Active

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Basic Information

Product Code
MWW
Device Class
FDA class 2
Regulation Number
892.5050
Medical Specialty
Radiology
Review Panel
RA
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.