FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLLIMATOR MODEL A280BLMD & MODEL A280BLMP
K Number: K861941
·
Decision Jul 25, 1986
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
5
Review Days
66
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Basic Information
- Device Name
- COLLIMATOR MODEL A280BLMD & MODEL A280BLMP
- K Number
- K861941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- D&R X-Ray Products, Inc.
- Date Received
- May 20, 1986
- Decision Date
- July 25, 1986
- Product Code
- IZX
- 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 |
|---|---|---|---|
| IZX | Collimator, Manual, Radiographic | FDA class 2 | Radiology |
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Other Clearances by D&R X-Ray Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862734 | CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND | Aug 1, 1986 | Substantially Equivalent |
| K861942 | COLLIMATOR MODEL A280BLE & MODEL A280-BLM | Jul 25, 1986 | Substantially Equivalent |
| K861940 | RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T | May 29, 1986 | Substantially Equivalent |
| K850948 | TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER | Apr 10, 1985 | Substantially Equivalent |