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PEDIAMETRIX INC

Matched from indexed company URL: PediaMetrix Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30208573813020857381PEDIAMETRIX INC1N2026-01-01155 Gibbs St. Suite 537 Rockville MD US 20850

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860009522206SoftSpot - SoftSpot is a software medical device that uses images of an infant's head to calculate cranial measurements, including Cranial Index (CI) and Cephalic Vault Asymmetry Index (CVAI). The SoftSpot platform allows users to capture and upload images for analysis and generation of measurement reports. The associated kit includes caps and accessories to support image capture quality. SoftSpot is intended for cranial measurement of infants from 1 month to 2 years of age in conjunction with other clinical methods.2406700171reza.seifabadi@pediametrix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2984642038827171K212045SoftSpotQQO2021-09-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QQO12021-09-28

PMN#

GUDID#

SoftSpot - SoftSpot is a software medical device that uses images of an infant's head to calculate cranial measurements, including Cranial Index (CI) and Cephalic Vault Asymmetry Index (CVAI). The SoftSpot platform allows users to capture and upload images for analysis and generation of measurement reports. The associated kit includes caps and accessories to support image capture quality. SoftSpot is intended for cranial measurement of infants from 1 month to 2 years of age in conjunction with other clinical methods.

PediaMetrix Inc.

2026-06-07