FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410
K Number: K853755
·
Decision Nov 26, 1985
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
40
Review Days
78
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Basic Information
- Device Name
- ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410
- K Number
- K853755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Victoreen, Inc.
- Date Received
- September 9, 1985
- Decision Date
- November 26, 1985
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
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| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Jun 16, 1995 | Substantially Equivalent |
| K940660 | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM | Dec 9, 1994 | Substantially Equivalent |
| K935435 | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST | Jul 29, 1994 | Substantially Equivalent |
| K941931 | DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR | May 26, 1994 | Substantially Equivalent |