Cleared Traditional

MODEL ND1100 BONE DENSITY SCANNER (K837230) - FDA 510(k) Clearance

K837230 · Molsgaard Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
12d
Days
-
Risk

K837230 is an FDA 510(k) clearance for the MODEL ND1100 BONE DENSITY SCANNER.

Submitted by Molsgaard Medical (2970 Horsholm, DK). The FDA issued a Cleared decision on May 18, 1983 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Molsgaard Medical devices

Submission Details

510(k) Number K837230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date May 18, 1983
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -