FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
K Number: K000052
·
Decision Feb 10, 2000
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
39
Applicant Total
9
Review Days
34
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Basic Information
- Device Name
- X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
- K Number
- K000052
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1760
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dynarad Corp.
- Date Received
- January 7, 2000
- Decision Date
- February 10, 2000
- Product Code
- ITY
- 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 |
|---|---|---|---|
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Dynarad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981267 | FACTS MONOBLOCK | May 6, 1998 | Substantially Equivalent |
| K973833 | CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL | Dec 30, 1997 | Substantially Equivalent |
| K932356 | NOVA XM2 | Feb 8, 1995 | Substantially Equivalent |
| K941363 | PHANTOM | Jul 20, 1994 | Substantially Equivalent |
| K932353 | HF-110A | Jan 31, 1994 | Substantially Equivalent |
| K932355 | 9150A, 1100F | Aug 3, 1993 | Substantially Equivalent |
| K932354 | 9170, 1170 | Jul 23, 1993 | Substantially Equivalent |
| K931725 | ALPHA II | Jul 14, 1993 | Substantially Equivalent |