FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVA XM2
K Number: K932356
·
Decision Feb 8, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
9
Review Days
636
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Basic Information
- Device Name
- NOVA XM2
- K Number
- K932356
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dynarad Corp.
- Date Received
- May 13, 1993
- Decision Date
- February 8, 1995
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
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Other Clearances by Dynarad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | Feb 10, 2000 | Substantially Equivalent |
| 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 |
| 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 |