Submission Details
| 510(k) Number | K073124 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 2007 |
| Decision Date | November 16, 2007 |
| Days to Decision | 10 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Abbreviated
COLLIMARE COLLIMATOR FAMILY
Nov 2007
Decision
10d
Days
Class 2
Risk
About This 510(k) Submission
K073124 is an FDA 510(k) clearance for the COLLIMARE COLLIMATOR FAMILY, a Collimator, Automatic, Radiographic (Class II — Special Controls, product code IZW), submitted by Collimare, LLC (Arvada, US). The FDA issued a Cleared decision on November 16, 2007, 10 days after receiving the submission on November 6, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.
Device Classification
| Product Code | IZW — Collimator, Automatic, Radiographic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1610 |
Manufacturer
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