SoftSpot

Primary DI
00860009522206
Brand
SoftSpot
Company
PediaMetrix Inc.
Model
SoftSpot
Device description
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.
Published
2026-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQOCranial Measurement Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQOCranial Measurement SoftwareGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009522206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009522206008600095222068600095222060860009522206

GMDN Terms#

Term, Definition table
TermDefinition
Posture imaging/analysis softwareA software program intended to be installed on a non-medical smart device with an integrated camera to allow a layperson to: 1) analyse posture based on captured body images for the calculation of body angles and possible misalignments (e.g., Cobb angle); and 2) store image data for tracking changes over time (e.g., misalignment progression). It typically utilizes artificial intelligence (AI) techniques to provide postural data from the images. It does not require clinical consultation; it may additionally be used by a healthcare professional.

Contacts#

Phone, Email table
PhoneEmail
2406700171reza.seifabadi@pediametrix.com

Regulatory Flags#

DUNS number
081060963
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false